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Number 61 June 2016 Editor: David W. Warne

Executive Committee (ExCom) 2016 Editorial

Officers Members

President,News Editor, Webmaster

David W. Warne (CH) Chris Metcalfe (UK) Katherine Lee (AU)

Vice-President KyungMann Kim (US) Chris Weir (UK) Stanislav Katina (CZ)Secretary Vana Sypsa (GR) Hein Putter (NL) Thomas Jaki (UK)Treasurer Zdenek Valenta (CZ) Jeremy Taylor (US) Toshiro Tango (JP)

Website and Email Addresses

www www.iscb.infoPermanent Office [email protected] [Rita Schou ]

Social Media

LinkedIn http://www.linkedin.com/groups?home=&gid=4795649

Facebook https://www.facebook.com/groups/139123109663/Twitter @ISCB_Info

ISCB News: Correspondence Address

ISCB News Editor [email protected] [David W. Warne]ISCB Book Review Editor [email protected] [Jindra Reissigova]

Chairs/Secretaries of Subcommittees (SCs) 2016

Student ConferenceAwards

Nadine Binder (DE) Katherine Lee (AU)

Statistics in RegulatoryAffairs

Harbajan Chadha-Boreham(FR)

Nicole Close (US)

National Groups Zdenek Valenta (CZ) Anca Vitcu (RO)

Epidemiology Saskia Le Cessie (NL) Christina Bamia (GR)

Education Erik Cobo (ES) Thomas Jaki (UK)

Conference Organising David W. Warne (CH) Geir Egil Eide (NO)

NG Representatives/Deputies/Treasurers/Webmasters/Websites 2016

Zdenek Valenta [email protected] Maly [email protected]

CzechRep.

Jindra Reissigová [email protected]

sites.google.com/site/iscbcr/home

Julia Singer [email protected] Boda [email protected]

Hungary

Péter Vargha [email protected]

efabis.univet.hu:8080/biostat

Krystyna Szafraniec [email protected] Alicja Cicha-Mikołajcz alicja.cichamikolajczyk@

gmail.com

Poland

Kinga Sałapa [email protected]

www.iscb.pl

Anca Vitcu [email protected] Ignat [email protected]

Romania

Elena Mitocariu [email protected]

iscbrng.vv.si

Jelena Kotur- Stevuljević

[email protected]

Dejan Ćurčić [email protected]

-

It’s only a few weeks to go until ISCB37 Birmingham, andit will be another large conference. Cindy Billingham andNigel Stallard of the LOC and SPC have written an article toprovide an overview of the event, and the full draftprogramme is included in this News. More details can befound at www.iscb2016.info where you can download thecomplete programme and the conference “app”.

Important Society business will be discussed at the AnnualGeneral Meeting (AGM) in Birmingham, to which allparticipants of the meeting are invited. The Agenda providedby ISCB Secretary Vana Sypsa is printed in this News. We willdiscuss the President’s mid-year Report, the TreasurerZdenek Valenta’s Financial Report of 2015, both included inthe News. Finally, the Subcommittees (SCs) will present briefupdates of their activities and we’ll have a preview of nextyear’s conference and plans for future years. Material will beplaced on ISCB’s website to review before the AGM.

It’s less than a year until the next ISCB Election and now isthe time to think whether you would like to become amember of the ExCom. The process is explained later in theNews. The Officers and ExCom would like to see people fromall parts of the ISCB membership becoming candidates.

Thanks to the contributors to this News: Zdenek Valentaand Nadine Binder on behalf of the NatG and StCA SCs forinformation about the 2016 CASc and StCA awards to bepresented in Birmingham, as well as Karla Hemming on behalfof the Conference Fund for Developing Countries (CFDC)awards committee. Thanks too to our Treasurer ZdenekValenta (Financial Report for ISCB 2015) and Secretary VanaSypsa (AGM agenda), new Book Review Editor JindraRessigova and the 3 book reviewers, Enrico Chavez foranother cartoon, and Rita Schou of the ISCB Office forkeeping everything under control.

Index

ISCB Membership .......................................................................................2ISCB President’s Mid-Year Message............................................................3ISCB Membership Progression....................................................................3Book Review by Miland Joshi (UK) ..............................................................4Oct. 2016 - Elections for the ExCom 2017-18: Final Warning! ....................5Books for Review by Jindra Reissigová (Book Review Editor) .....................6Book Review by Douglas Dover (CA)...........................................................8ISCB Treasurer’s Mid-Year Report: ISCB Accounts 2015 .............................9ISCB37 Birmingham, UK: 21-25 August 2016: Welcome!..........................11ISCB37 Birmingham 2016: Conference Awards for Scientists: Winners....12ISCB37 Birmingham 2016: Student Conference Awards: Winners............12ISCB37 Birmingham 2016: Biometrical Journal Special Issue ....................12ISCB37 Birmingham 2016: Students’ Day..................................................13ISCB37 Birmingham 2016: ISCB Annual General Meeting Agenda............14

ISCB37 Birmingham 2016: Conf. Fund for Developing Countries (CFDC).. 14Book Review by Matthias Herpers (DE).................................................... 31Cartoon Corner ........................................................................................ 32ISCB GENERAL INFORMATION.................................................................. 33Advertising Rates ..................................................................................... 33Society’s Aims .......................................................................................... 33Changes of Address or Email .................................................................... 33Information on Submitting Articles .......................................................... 33ISCB Office & Executive Committee: Contact Details ............................... 34ISCB Membership and Googlegroups Emailing Lists................................. 35ISCB Subcommittees: Contact Details ...................................................... 36ISCB Membership Information................................................................. 38ISCB Membership Subscription ................................................................ 39ISCB Calendar ........................................................................................... 40

ISCB News #61 June 2016

ISCB Membership

ISCB membership continues to grow to another new record June total. The idea of introducing a €20 surcharge for late subscription may have had an impact.Also new members who have joined ISCB by attending the conference in Birmingham have been added to the membership database on an ongoing basisfrom April. If you haven’t yet logged on to the Members Area of the www.iscb.info website, please have a go; if you need any help, please [email protected].

Date end end Dec Dec Dec Dec Dec Dec Dec Nov Nov Dec Nov Nov Nov Nov Nov Dec Nov Dec Dec Dec Dec Dec Jun Dec Jun

*=host Conference 89 92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 15 16 17 18 19

Total 261 596 715 698 725 702 685 729 818 797 837 825 756 758 620 808 800 921 862 880 864 993 1028 1084 635 1141 883

# Countries 23 32 32 31 33 34 37 37 41 40 45 41 40 38 39 40 41 42 39 42 41 43 42 55 41 50 45

1. UK 50 90 176* 120 144 121 128 169* 135 151 153 141 190* 140 109 133 117 114 124 114 99 130 130 121 61 144 189*

2. Poland [NatGrp] 11 11 24 24 30 21 19 26 34 37 41 41 43 40 49 54 62 66 71 78 82 88 88 84 86 76

3. Germany 30 67 75 84 71 78 72 70 186* 90 87 77 61 57 51 73 48 59 72 61 53 78 113* 107 44 108 70

4. Romania [NatGrp] 2 4 1 1 1 19 21 30 28 30 31 36 2 67 58 67 72 75 77 68

5. Hungary [NatGrp] 1 21 17 18 19 25* 27 29 29 33 34 41 48 42 38* 50 44 43 44 42 48 48 49 52 52 52 52

6. Czech Rep. [NatGrp] 1 1 1 1 1 1 2 2 1 1 1 1 3 17 36 28 44* 30 30 41 40 43 42 42 43

7. Netherlands 14* 30 38 33 36 29 31 39 35 33 38 39 33 87* 35 44 41 39 49 56 38 57 55 55 38* 111 42

8. France 30 52 62 50 73 67 52 52 49 53 37 93* 31 41 30 57 41 49 49 119* 48 60 66 70 23 72 42

9. USA 18 45 40 39 41 40 79* 66 76 77 89 78 75 57 51 67 62 74 67 64 93 66 63 57 36 57 37

10. Japan 2 6 7 5 7 4 10 13 20 12 11 10 10 10 17 17 27 20 26 24 22 9 38 30 11 27 25

11. Australia 6 9 11 6 9 8 11 9 10 12 8 9 14 8 6 11 11 10 13 18 17 23 31 24 16 25 21 *

12. Denmark 4 58* 38 31 30 32 26 35 38 39 36 46 41 37 37 40 34 154* 54 60 39 50 39 29 17 29 20

13. Canada 6 12 14 14 11 13 15 14 9 9 10 14 16 8 12 12 19 22 18 18 68* 14 17 24 15 27 18

14. South Korea 3 1 1 1 6 6 6 5 6 15 22 12 18

15. Switzerland 14 25 22 80* 33 29 24 25 23 18 23 26 22 23 23 55* 28 26 28 30 15 20 29 37 12 32 17

16. Norway 13 18 25 22 12 18 10 10 11 10 16 16 12 14 12 13 12 19 21 15 15 70 34 27 13 24 17

17. Austria 4 9 11 13 11 16 13 11 15 18 15 13 16 17 15 14 16 17 15 15 9 10 15 45* 10 15 16

18. Belgium 13 22 27 30 30 32 35 29 25 33 36 33 23 27 24 23 32 33 33 32 24 32 35 21 8 28 15 *

19. Turkey 1 1 1 1 2 2 3 4 7 2 3 1 2 5 5 20 11

20. Sweden 23 51 53 54 58 64 51 45 38 44 88* 50 36 34 24 23 19 27 19 18 12 26 13 18 8 15 11

21. Italy 16 33 37 32 32 33 26 33 26 63* 29 25 15 25 15 23 24 20 10 15 8 24 9 16 7 9 11

22. Greece 1 1 1 1 1 3 1 6 1 2 2 3 50* 5 7 7 5 7 11 8 4 13 8

23. Spain 10 12 18 12 46* 23 14 16 12 11 11 8 7 15 5 9 8 5 14 14 4 13 10 17 6 8 8 *

24. Taiwan 1 1 1 1 1 1 3 7 4 3 5 2 5 6

25. India 1 1 1 1 1 1 1 1 2 1 2 2 3 2 2 3 4 4 3 8 8 6 7 3 3 5

26. Finland 2 7 7 9 9 9 7 5 10 9 18 11 7 11 10 6 8 8 9 8 6 9 11 4 3 7 3

27. South Africa 1 4 1 3 2 2 2 2 2 3 3 3 2 3 3 3 2 5 2 4 4 1 2 1 5 3

28. Russia 1 3 3 3 2 2 1 4 3 2 1 1 1 1 1 2 4 3

29. Slovakia 1 1 2 2 2 2 1 1 1 3 3 3 3 3

30. Bulgaria 1 2 1 1 2 3

31. Ireland 1 2 3 4 3 4 4 2 3 2 3 1 1 2 1 3 3 3

32. Sri Lanka 1 1 1 3

33. Iran 1 1 1 1 4 1 3 5 1 2 1 6 3 2 1 9 2

34. Slovenia 1 2 3 2 1 1 3 2 1 2 1 2 3 3 4 5 5 4 3 6 4 2 7 7 9 2

35. Israel 1 3 4 4 4 4 3 3 4 10 13 10 7 8 3 4 2 2 1 2 2 3 2 7 1 5 2

36. Portugal 1 3 5 2 2 2 2 5 5 3 4 3 3 1 1 1 2 6 2 7 2 3 1 10 2 3 2

37. Singapore 3 6 4 5 8 5 7 2 4 6 2 4 1 3 3 5 1 1 3 2

38. New Zealand 1 1 2 1 2 2 2 3 3 3 1 2 2 2 5 2 1 3 1 2 3 1 7 1

39. Thailand 1 1 1 1 2 1 1 2 2 2 3 1 3 5 1

40. Brazil 2 1 1 1 1 2 2 2 2 2 2 1

41. Luxembourg 1 1 2 1 3 1 2 1

42. Kenya 1 1 1 1 1 1 1

43. Colombia 1 1 1 1 1 1 1

44. Nigeria 1 1

45. Egypt 1 1 1

46. Serbia [NatGrp] 2 13 13 10 11 16 16

47. Bangladesh 1 4

48. China 1 1 2 3 3 3 3 3 3 3 2 2 2 2 3 1 2

49. Mexico 1 1 1 1 1 1 2 2 2 1 1 1 1 2 1 2

50. Estonia 2 1 1 1 1 1 3 2

51. Pakistan 1 1 1 1 2

52. Malaysia 2 1 2 2 1 1 1 1 1 3 3 2 1 1 2 3 2 1 1 1

53. Qatar 1 1 1 1

54. Vietnam 1 1 3

55. Jordan 2

56. Gambia 1 2

57. Venezuela 2 1 1

58. Saudi Arabia 1 1 3 1

59. Indonesia 1 1 1 1

60. Croatia 1 1 1 1

61. Kuwait 1 1 1

62. Cyprus 1

63. Argentina 1 1

64. Algeria 2

65. Cuba 2 2 2 2 2 2 1 1 1 1

66. United Arab Emirates 1 1

67. Chile 1

68. Malawi 1 1 1

69. Lithuania 2

70. Sudan 1

71. Ukraine 1 1

72. Philippines 1

73. Zimbabwe 1

74. Oman 1


ISCB President’s Mid-Year Message

From David W. Warne

Firstly, and most importantly, the Ballot for choosing the newExecutive Committee and Officers (Vice-President, Secretaryand Treasurer) for 2017-18 is fast approaching. An article in thisNews lists which positions are open for nominations andexplains the process.

I would like each of you to consider submitting a nominationform by the deadline of 31 August 2016. Do you have somethingto contribute to the Society? Do you think there are not enoughpeople from your country or region involved in the Society’sdecision-making? Are there not enough members of theCommittee who are women? Is it always the same old group ofpeople making decisions or should we have some new bloodbringing new, fresh ideas?

The Society is beginning to look for Conference Candidates for2020 and later. If you and your friends and colleagues would liketo organise an ISCB conference, now is the time to explore theinitial ideas. A good conference can take 5 years fromconception to birth!

As announced in Utrecht, the Society has found a new journal topublish some of the best papers presented at the annualconference. This will allow us to continue the tradition of havingan ISCB Special Issue, which goes back about 30 years. Latestnews is that 12 papers from Utrecht were submitted to theBiometrical Journal. This process will be continued for ISCB37Birmingham, please see the article in this News.

The organisers of ISCB36 Utrecht took a risk and set theconference fee low to try to encourage more people to attendand to avoid having too profit. Now that the accounts are beingfinalised, it’s clear they got things just right.

The ISCB Treasurer’s report from Zdenek Valenta, shows thatthe financial results of 2015 were positive confirming that theSociety is financially very healthy. This is clearly correlated withmore members joining the Society by attending the annualconference.

This year’s conference, ISCB37 Birmingham, promises to be again veryexciting. The organising and scientific committees have done almostall their work and are awaiting the arrival of us, the ISCB members inthe final week of August, Sunday 21 to Thursday 25. Full details areincluded in this News.

If you attended the conference in Utrecht, you will have seen manyinteresting sessions and attended some of the social activities. Butperhaps you’re not aware the Society is active between conferences,especially its 6 Subcommittees (SCs). Have you thought about joiningone of them? The following summarises their activities.

The Student Conference Awards SC continues to review how it canimprove its processes and find new ways to get students involved inISCB. See the article below about a special Students Day planned forBirmingham.

The Statistics in Regulatory Affairs SC is planning to launch aWikipedia website linking to various guidances on biostatistics. Theyhave had an abstract accepted for ISCB37 in Birmingham and so pleaselook out for their poster P-182.

The National Groups SC has been very active with the organisation ofseveral seminars within each NG country.

Members of the Epidemiology SC will present updates of the STRATOSinitiative in Birmingham, and the initiative continues to grow andrecruit more members to its various work streams. The rest of theEpid SC is considering whether to continue its work on other topics.

The Education SC again has asked for proposals and suggestions forbiostatistics courses in 2016. Two courses will be given:

Budapest, Hungary, Nov 2016, Stephen Senn: Statistical issues in drugdevelopment

Krakow, Poland, 22-23 Sep 2016, Stijn Vansteelandt: Models for CausalInference

Lastly, the Conference Organising SC continues to discuss ways toimprove conferences and will advise the Society’s Officers on futureconference candidates.

ISCB Membership Progression

ISCB Membership 1992-2016

596

715698

725702

685

729

817797

838 825

780760

619

808 800 808 800

921

862880

864

992

1028

1084

1141

0

430 439 428 442 434 448480 469

518 523483

433 436467

450467

448413

458437

517475

547

596635

883

0

200

400

600

800

1000

1200

Dec

92

Dec

93

Dec

94

Dec

95

Dec

96

Dec

97

Dec

98

Dec

99

Dec

00

Dec

01

Dec

02

Dec

03

Dec

04

Nov

05

Nov

06

Nov

07

Nov

06

Nov

07

Dec

08

Nov

09

Dec

10

Nov

11

Dec

12

Dec

13

Dec

14

Dec

15

Dec

16

end mid


Book Review by Miland Joshi (UK)

Marschner, Ian C Inference Principles for Biostatisticians CRC 2015 9781482222234

The title of this book suggests something differentfrom the usual textbook on Statistical Inference in twoways: a wider perspective and guidance on strategy(“Principles”), and an emphasis on applications inMedical Statistics. A look at the bibliography shouldreassure readers; many of the entries are well-knownitems used in advanced undergraduate or Masters’courses in Statistics.

From the preface, this book occupies a special place inthe curriculum: assuming basic mathematical andstatistical knowledge, it tries to lay a foundation forlater courses in special topics like statistical modellingand clinical trials. This would make it a goodintroductory text for Master’s students (or possiblyadvanced undergraduates). The features on the backcover mention R functions, but the reader should notethat this only applies to a restricted set of simulationprograms, filling 7 pages in Appendix 2 – and that’s all.Thus R is very much a minor part of the book, formingno part of the main text, which is a concise text onstatistical inference. An introductory intensive revisionof probability theory is followed by chapters onestimation, likelihood, and hypothesis testing, and afinal chapter on Bayesian methods. Profile likelihoodsare discussed briefly (without diagrams, butconditional, marginal and partial likelihoods aredismissed immediately after being mentioned byname, the reader being referred to Cox’ 2006 book as astarting point. If these are to be mentioned at all, itwould be helpful to also be given some idea of whatthey mean and how they are used in Biostatistics. Theapproaches of Likelihood ratio, Wald tests and scorestests are compared, but as with profile likelihood, nodiagrams are included. In this section, the Neyman-Pearson lemma is mentioned informally without proofand dismissed as unimportant.

The chapter on Bayesian methods mentions the subjectivenature of priors, but there is no discussion of evidence-based priors. If priors cannot be justified in this way, theyrisk being treated either as purely subjective (and so foreversuspect) or just a computational convenience –a startingpoint in a process that yields a useful answer.

In a similar way that earlier chapters did with unusuallikelihoods, the Bayesian chapter refers to MCMC as beyondthe scope of the book and refers the reader to otherauthors. To be fair, it only claims to be a brief introduction.

One strength of the book is that an extended exampleillustrating the methods is given at the ends of mostchapters. Exercises are also included, though withoutanswers. There is a helpful Appendix summarising factsabout common distributions, making the book useful forreference.

The fact that the book is intended as a foundation for morespecialised courses partly explains why the reader issometimes referred to further reading e.g. on unusuallikelihoods, or MCMC. Even if so it would be helpful for thebook to be more self-contained. Other things that wouldhelp to this end would be more teaching diagrams and theprovision of R code throughout the text, not to mentionsolutions to exercises. All this would, of course, make thebook larger.

All in all, this may be a useful book when accompanying ataught course which is part of a curriculum leading to morespecialised courses, but as it stands, I would not recommendit for self-learning.


Oct. 2016 - Elections for the ExCom 2017-18: Final Warning!

From Vana Sypsa, Secretary and David W. Warne, Nominations Officer

In accordance with the Constitution, we ask for nominations for positions on the Executive Committee for2017-18. At the end of 2016, the situation will be:

David W Warne Will retire as President andbecomes Past President for one year, 2017.

KyungMann Kim After being Vice-President for 2015-16,will become President for 2017-18 andPast-President for 2019.

Vana Sypsa Will end her 2nd term as Secretary andis not eligible for re-election as Treasurer or Secretary butis eligible for election as Vice-President.

Zdenek Valenta Ends his 1st term as Treasurer andis eligible for re-election as Treasurer, Secretary or Vice-President.

Chris MetcalfeJeremy Taylor

End their 2nd terms as Ordinary members andare not eligible for re-election as Ordinary members, butare eligible for re-election as Treasurer, Secretary or Vice-President.

Chris Weir, Hein PutterKatherine Lee ,Stanislav KatinaThomas Jaki, Toshiro Tango

End their 1st terms as Ordinary members andare eligible for re-election as Ordinary members, or asTreasurer, Secretary or Vice-President.

David W Warne Wishes to continue as News Editor and Webmaster.

Nominations for

Vice-President,

Secretary,

Treasurer and

8 ordinary members

are therefore sought.

To make a nomination, please download the form from theweb[www.iscb.info/files/folders/nominations/iscb_template_nomination_2016.doc] and send it to the Chair of the ISCBNominations Committee, David W. Warne([email protected]).

Each nomination will require the signatures of the Proposer,a Seconder and of the Nominee confirming a willingness toserve. Completed and signed nomination forms must bereceived no later than 31 August 2016 (scanned forms sentby email are acceptable.)

If there are more nominees than vacant positions, anelectronic ballot will be held.

NB Please note the following important clauses from theISCB Constitution(http://www.iscb.info/files/folders/constitution_2012-12-31.pdf):

(6.02) The Committee shall consist of the four Officers and at leastfive but not more than eight other members (“Ordinarymembers”), plus the Past President, who shall serve only for thecalendar year immediately following the Presidency, and co-optedmembers.

(6.03) The Ordinary members, who shall be Members for at leastthe calendar year prior to nomination, must be elected by ballot;their full term of office shall be two calendar years and they shallbe eligible for re-election for one further full term up to amaximum of four consecutive calendar years.

(6.06) The Executive Committee must meet at least once at aConference of The Society and at least once during any calendaryear; at least thirty days notice of such meetings must be given toall Executive Committee members by the Secretary.

(6.07) Meetings of the Executive Committee shall normally bearranged by agreement among members present at an earliermeeting or by agreement among The Officers.

Meetings may also be called by agreement of a majority of the fullcurrent membership of the Executive Committee.

(6.08) Any member of the Executive Committee who fails toattend Committee meetings for two consecutive calendar yearswithout providing sufficient explanation for absence to thePresident and Secretary shall cease to be a member, and cannot bere-elected.

(15.06) Nominations must be proposed and seconded byMembers, are subject to the agreement of the Nominee, and mustbe accompanied by the names and signatures of all three.

*No Member may be nominated for the posts of two Officers atthe same ballot, but may be nominated both as an Officer and asan Ordinary member of the Executive Committee.


Books for Review by Jindra Reissigová (Book Review Editor)

Important note to potential reviewers:

We regularly receive books from publishers for review inthe Newsletter. We are most grateful for these“donations”, the reviews of which we regard as a serviceto you, our members. Regretfully, some individuals,despite repeated reminders, neither return a review, northe book to ISCB... When requesting a book, pleaseremember that you’re making a commitment to theSociety to do a little work in return for keeping the book.

Please do a little work in return for keeping the book andyour name will be published in the News!

For the format and length, please see recent issues ofISCB News. You can send the review in a variety offormats but plain text email, html, RTF or Word arepreferred. The reviews may be edited for clarity (Englishgrammar and spelling, punctuation etc.).

[email protected]

For updates between Newses, please see:

http://www.iscb.info/Members-Area/Books-for-Review.html

Author(s) Books for review: Title Publisher Year ISBN

1. Casals, Jose, Garcia-Hiernaux, Alfredo, Jerez, Miguel,Sotoca, Sonia, Trindade, Alexandre A

State-Space Methods for Time Series Analysis: Theory,Applications and Software

CRC 2016 9781482219593

2. Chang, Mark Monte Carlo Simulation for the Pharmaceutical Industry CRC 2011 9781439835920

3. Chang, Mark Adaptive Design Theory and Implementation Using SAS and R (2nd

ed.)CRC 2014 9781482256598

4. Chen, Joshua, Quan, Hui Multiregional Clinical Trials for Simultaneous Global New DrugDevelopment

CRC 2016 9781498701464

5. Cheung, Ying Kuen Dose Finding by the Continual Reassessment Method CRC 2011 9781420091519

6. Chow, Shein-Chung Design and Analysis of Bioavailability and Bioequivalence Studies(3rd ed.)

CRC 2009 9781584886686

7. Jones, Byron, Kenward, Michael G Design and Analysis of Cross-Over Trials (3rd ed.) CRC 2014 9781439861424

8. Khan, Iftekhar Design & Analysis of Clinical Trials for Economic Evaluation &Reimbursement: An Applied Approach Using SAS & STATA

CRC 2015 9781466505476

9. Kupper, Lawrence L, Neelon, Brian, O’Brien, Sean M. Exercises and Solutions in Biostatistical Theory CRC 2010 9781584887225

10. Lawson, Andrew B, Banerjee, Sudipto, Haining,Robert P, Ugarte, Dolores, Maria

Handbook of Spatial Epidemiology CRC 2015 9781482253016

11. Li, Jialiang, Ma, Shuangge Survival Analysis in Medicine and Genetics CRC 2013 9781439893111

12. Liu, Jen-pei, Chow, Shein-Chung, Hsiao, Chin-Fu Design and Analysis of Bridging Studies CRC 2012 9781439846346

13. Matsui, Shigeyuki, Buyse, Marc, Simon, Richard Design and Analysis of Clinical Trials for Predictive Medicine CRC 2015 9781466558151

14. Sverdlov, Oleksandr (ed.) Modern Adaptive Randomized Clinical Trials: Statistical andPractical Aspects

CRC 2015 9781482239881

15. Wang, Jixian Exposure–Response Modelling: Methods and PracticalImplementation

CRC 2015 9781466573208

16. Yang, Harry, Zhang, Jianchun, Yu, Binbing, Zhao, Wei Statistical Methods for Immunogenicity Assessment CRD 2015 9781498700344

17. Young, Walter R, Chen, Ding-Geng Clinical Trial Biostatistics and Biopharmaceutical Applications CRC 2015 9781482212181

18. Zhao, Wei, Yang, Harry (eds.) Statistical Methods in Drug Combination Studies CRC 2014 9781482216745


Books for Review (continued)

Author(s) Reviews in this issue: Title Publisher Year ISBN Reviewer (country)

Marschner, Ian C Inference Principles for Biostatisticians CRC 2015 9781482222234 Miland Joshi (UK)

Peace, Karl E Design and Analysis of Clinical Trials withTime-to-Event Endpoints

CRC 2009 9781420066395 Matthias Herpers (DE)

van Buuren, Stef Flexible Imputation of Missing Data CRC 2012 9781439868249 Douglas Dover (CA)

Author(s) Sent recently: Title Publisher Year ISBN Reviewer (country)

Ahn, Chul, Heo, Moonseoung,Zhang, Song

Sample Size Calculations for Clustered andLongitudinal Outcomes in Clinical Research

CRC 2015 9781466556263 Sada Nand Dwivedi (IN)

Ahn, Chul, Heo, Moonseoung,Zhang, Song

Sample Size Calculations for Clustered andLongitudinal Outcomes in Clinical Research

CRC 2015 9781466556263 Beth Stuart (UK)

Anderson, Stewart J Biostatistics - A Computing Approach CRC 2012 9781584888345 Caroline Haig (UK)

Baio, Gianluca Bayesian Methods in Health Economics CRC 2012 9781439895559 Anna Bartkowiak (PL)

Baldi Antognini, Alessandro,Giovagnoli, Alessandra

Adaptive Designs for Sequential TreatmentAllocation

CRC 2015 9781466505759 Sada Nand Dwivedi (IN)

Berry, Scott M,Carlin, Bradley P, Lee, J Jack,Muller, Peter

Bayesian Adaptive Methods for Clinical Trials CRC 2010 9781439825488 Susanne Urach (AT)

Collett, David Modelling Survival Data in Medical Research(3rd ed.)

CRC 2014 9781439856789 Giulia Barbati (IT)

Commenges, Daniel, Jacqmin-Gadda, Helene

Dynamical Biostatistical Models CRC 2015 9781498729673 Per Kragh Andersen (DK)

Cosmatos, Dennis,Chow, Shein-Chung (eds.)

Translational Medicine: Strategies andStatistical Methods

CRC 2008 9781584888727 Erik Cobo (ES)

Crowley, John, Hoering, Antje Handbook of Statistics in Clinical Oncology (3rd

ed.)CRC 2012 9781439862001 Attila Dávid (HU)

De Leon, Alexander R,Chough KC

Analysis of Mixed Data - Methods andApplications

CRC 2013 9781439884713 Abhik Ghosh (NO)

Fullerton, Andrew S, Xu, Jun Ordered Regression Models: Parallel, Partial,and Non-Parallel Alternatives

CRC 2016 9781466569737 Marek Brabec (CZ)

Gandrud, Christopher Reproducible Research with R and RStudio CRC 2014 9781466572843 Caroline Haig (UK)

Geskus, Ronald B Data Analysis with Competing Risks andIntermediate States

CRC 2015 9781466570351 Sophie Tézenas du Montcel(FR)

Gibbons, Robert D, Amatya,Anup

Statistical Methods for Drug Safety CRC 2015 9781466561847 Maria de Ridder (NL)

Golbeck, Amanda L, Olkin,Ingram , Gel, Yulia R (eds.)

Leadership and Women in Statistics CRC 2015 9781482236446 Marianne Huebner (US)

Klein, John P,van Houwelingen, Hans C,Ibrahim, Joseph G,Scheike, Thomas H

Handbook of Survival analysis CRC 2014 9781466555662 Jordi Cortés Martínez (ES)

Li, Jialiang, Ma, Shuangge Survival Analysis in Medicine and Genetics CRC 2013 9781439893111 Victor Moreno (ES)

Marschner, Ian C Inference Principles for Biostatisticians CRC 2015 9781482222234 Cono Ariti (UK)

Newcombe, Robert G Confidence Intervals for Proportions andRelated Measures of Effect Size

CRC 2012 9781439812785 David W. Warne (CH)

Ng, Tie-Hua Noninferiority Testing in Clinical Trials - Issuesand Challenges

CRC 2014 9781466561496 Beth Stuart (UK)

Author(s) Sent a long time ago: Title Publisher Year ISBN Reviewer (country)

Jackson, J Edward A User’s Guide to Principal Components Wiley 2003 9780471471349 Nicole Close (US)

Rothman, Mark D,Wiens, Brian L, Chan, Ivan SF

Design and Analysis of Non-inferiority Trials CRC 2011 9781584888048 Sebastien Marque (FR)

Shoukri, Mohamed M Measures of Inter-observer Agreement andReliability (2nd ed.)

CRC 2010 9781439810804 Elisabeth Svensson (SE)

Publisher Webpages: (checked 17June2016)

Cambridge University Press http://www.cambridge.org/ch/academic/subjects/statistics-probability/

CRC (Taylor and Francis) https://www.crcpress.com/statistics

Oxford University Press https://global.oup.com/academic/category/medicine-and-health/medical-statistics-and-methodology

Springer https://www.springer.com/gp/statistics

Wiley* http://eu.wiley.com/WileyCDA/Section/id-351216.html

*Details of Wiley special offers can be found on the ISCB website as follows:

http://www.iscb.info/Members-Area/Welcome.html which includes the book discount and

http://www.iscb.info/Join-Us/Special-Offer-to-Members---Wiley.html which includes the Statistics in Medicine special rate.


Book Review by Douglas Dover (CA)

van Buuren, Stef Flexible Imputation of Missing Data CRC 2012 9781439868249

As an applied biostatistician, the introductory chapterspoke directly to me. It began motivating the issues inmultiple imputation from the perspective of applied dataproblems and problematic approaches to them.

Chapter 2 provides the theory and definitions underlyingmultiple imputation. The concepts are clearly explainedwith practical intuitions always given in parallel. Sectionsdelving deeper into theoretical issues are clearly marked,and can be read or skipped at the reader’s preferencewithout loss of continuity.

The meat of this book begins in Chapter 3. The first partassumes an ignorable missing data mechanism, thesecond part does not in the analysis of univariate missingdata. The chapter begins by building up the theory behindwhat needs to be included in any multiple imputationmethod and goes on to describe a number of methods fora variety of data types. In fact, this chapter is really the“gentle introduction to the practice of multipleimputation”. Foundational examples start with simplescenarios that are gradually and clearly expanded upon.At each step, R code is shown and illustrations visuallyshow the effects of different approaches. For every majorconcept there is a half-page “Algorithm Box”, a shortsummary in pseudo-code of the algorithm beingdiscussed. These, in conjunction with the explanatorytext, made things extremely clear and easy to grasp.Much to my pleasure, the theory was complemented witha constant commentary on the performancecharacteristics of the methods – circumstances when theyworked well, areas where the performance characteristicswere not yet know, how many iterations are sensible touse in practice. This was particularly helpful to build theframework of potential methods that would work in mycircumstances.

Moving from univariate to multivariate missing dataoccurs in Chapter 4. Patterns of missing data are clearlyexplained and illustrated, and then methods are clearly

linked back to this structure. In essence, Chapter 4 readslike a meta-algorithm chapter: for multivariatemissingness, identify the pattern, work within it applyingthe same concepts introduced in the univariate chapter.Of course, the joint and fully conditional methods specificto multivariate data are discussed in detail, as are thereperformance characteristics. My only regret at the end ofthis chapter was that there was no discussion on thedesign of missingness (although there is a paragraph laterin Chapter 10 citing some references). The description ofthe patterns of missingness touched on the fact thatcertain designs could be intentionally created. Adiscussion of how best to do this would have made this amuch richer chapter for those who influence datacollection in addition to carrying out the analysis.

Chapter 5 pull together the theory and explicitly identifiesthe decision points needed in any analysis. A number ofspecific data situations are discussed. Performancecharacteristics and practical rules of thumb continue tobe present, along with the example data. Chapter 6 goeson to describe how to actually analyse data once themultiple imputations have been carried out. The basicprinciples as well as special cases are covered.

Chapters 7-9 cover detailed examples of missing datasituations and approaches. The context is fully explained,the issue identified, methods applied and results shown,and pitfalls identified and dealt with. These chaptersclearly draw upon the author’s real-life analyses, makingthem invaluable experiences to learn from. The finalchapter summarises the risks and rewards of usingmultiple imputation and directs the reader to sources fora variety of emerging and specialized applications ofmultiple imputation.

Overall, this book does an excellent job of bringing onefrom no knowledge of multiple imputation to a workingknowledge of multiple imputation.


ISCB Treasurer’s Mid-Year Report: ISCB Accounts 2015

From Zdenek Valenta

Although wrapping up the Utrecht conferenceaccounts experienced some delays, the accountdetails were reviewed during the Officers’ andExCom Skype teleconference on 26 and 27 May2016, respectively. Minor issues with tracking theSociety membership dues paid as part of Utrechtconference registration were resolved thanks to adiligent work of Rita Schou in the Copenhagen ISCBOffice. In accord with Utrecht LOC’s proposal, theOfficers and ExCom decided to honour half of notpreviously agreed costs claimed by the Utrechtconference organising agency related to extra hoursspent on the job. However delicate that issue mayappear, the future LOCs need to pay detailedattention to agreed costs to avoid last minute claimsby the PCO.

A summary of the ISCB’s financial standing as of 31December 2015 is shown below. It will be furtherdiscussed during the ExCom meeting and the AnnualGeneral Meeting at ISCB37 in Birmingham, UK, inAugust 2016.

The accounts of ISCB36 in Utrecht, the Netherlands,are going to be audited by an internal ISCB auditaccording to §10.07 in the ISCB’s Constitution.Subsequently, the Society’s full accounts for thefiscal year 2015 will be audited byPricewaterhouseCoopers StatsautoriseretRevisionspartnerselskab in Copenhagen, Denmark.The PWC approval may be expected in July 2015 thelatest.

Based on the preliminary financial report for 2015, theSociety's financial standing has slightly improved with asurplus of €17,608.

The Society’s expenses steadily increased from €46,489 in2011 to €55,942 in 2012, €49,393 in 2013, €53,202 in2014 and €76,625 in 2015. The latter increase reflects theSociety’s decision to provide financial support toresearchers from developing countries using a so-called‘15k’ or ‘CADC’ fund. Total support worth 14,340 EUR wasprovided in 2015 using this fund and the Society willcontinue this support scheme in 2016.

Society’s recent income was €59,210 in 2012, €85,600 in2013, €123,922 in 2014 and €94,233 in 2015. Despitefairly moderate Utrecht conference fees and a fairamount of support being allocated to various award andsupport schemes (StCA, CASc and 15k/CADC), the ISCBequity position went up in 2015 by more than €18,000.

The income from membership fees has grown steadilyfrom €22,280 in 2011, €25,460 in 2012, €26,240 in 2013,€27,900 in 2014 and €29,420 in 2015, reflecting acontinual enlargement of the ISCB membership base.

In 2015 the equity position of the ISCB increased from€388,613 as of 31 December 2014 to €406,221 as of 31December 2015.


ISCB Treasurer’s Mid-Year Report

INTERNATIONAL SOCIETY FOR CLINICAL BIOSTATISTICS:FINANCIAL REPORT for JANUARY-DECEMBER 2015

Draft 5 2015 Euro 2014 Euro

IncomeMembership fees 29,420.00 27,900.00Conference surplus 64,513.26 94,358.97Course surplusAdvertising 300.00 1,350.00Earned interestCurrency gains 312.58

Total income 94,233.26 123,921.55

ExpenditurePermanent Office:

Consumables 6.69Postage & freight 45.82 44.50Telecommunication & internet 2,485.46 2,044.88Ballots 68.43 2,911.24Printing & photocopying 65.71Administration 15,375.00 15,000.00

17,981.40 20,066.33Officers & ExCom:

Conference fees 4,400.00 5,825.00Accommodation 4,410.45 2,737.87Travel expenses 2,849.22 2,659.97Other expenses 1,120.97 523.43

12,780.64 11,746.27Awards (Students, Scientists):

Conference fees 2,760.00 2,050.00Accommodation 4,524.80 1,575.00Travel expenses 4,058.39 2,018.81Other expenses 158.00 53.43

11,501.19 5,697.24President’s Invited Speaker

Conference fees 440.00Accommodation 141.34Travel expenses 75.59Other expenses

656.93 0.00Workshops / Courses:

Honorarium 1,900.00Accommodation 50.00Travel expenses 750.00 194.00Other expenses 800.00

750.00 2,944.00Newsletter:

Office expenses 11,176.87 6,428.94AccommodationTravel expenses

11,176.87 6,428.94Other items:

Bank charges 1,729.41 999.13Interest 354.68Audit 2,200.00 2,270.00Currency fluctuations 265.46 -0.58National Groups travel support 2,889.35 3,050.93Conference Awards Developing Countries 14,339.43

21,778.33 6,319.48Total expenditure 76,625.36 53,202.26NET INCOME: 17,607.90 70.719.29

AssetsBank accounts:

Nordea DKK account 139,020.49 139,400.34Nordea Euro account 185,965.14 134,992.70

324,985.63 274,393.04Others:

Accounts receivable 593.28Vienna, 2014 99,746.03Utrecht, 2015 89,598.41 30,000.00Birmingham, 2016 5,811.94

95,410.35 130,339.31Total Assets 420,395.98 404,732.35Liabilities

Owing to Permanent Office 11,158.23 10,888.85Audit 2,200.00 2,270.00Prepayment account, members 40.00 40.00Accounts payable 776.80 2,920.45

Total Liabilities 14,175.03 16,119.30Assets less Liabilities 406,220.95 388,613.05

EQUITY brought forward 388,613.05 317,893.76Profit/loss by 31 December 2014 70,719.29Profit/loss by 31 December 2015 17,607.90EQUITY carried forward 406,220.95 388,613.05

Draft 5: 28Jun2016Conversion rate: 31-12-2015 100 EUR = 746.25 DKK


ISCB37 Birmingham, UK: 21-25 August 2016: Welcome!

From Lucinda Billingham (LOC Chair) and Nigel Stallard (SPC Chair)

The city of Birmingham is proud to host the 37th

annual conferenceof ISCB. The Local Organising Committee and Scientific ProgrammeCommittee have been working together to create an excitingscientific and social programme.

We have 25 world-class invited speakers including two outstandingkeynote plenary speakers, 245 contributed oral presentations andaround 200 posters. We have 6 pre-conference courses includingtwo half-day courses that cover a broad range of topics. We havere-introduced the mini-symposium on Thursday with a choice oftwo key themes that are also available to non-participants of theconference.

In addition this year we have introduced a new Student Day onThursday which is open to recently graduated or current PhDstudents with the aim to stimulate discussion on how to be a goodresearcher and how to come up with biostatistical researchprojects of ongoing or future interest.

Birmingham is the second largest city in the UK and is situated rightin the heart of England. It is a city of culture, combined with superbshopping, great night life and award winning restaurants and hasstrong links to the scientific community through the University ofBirmingham. The conference venue is the world class InternationalConvention Centre in the centre of the city located on the historicBirmingham canal, next to the stunning new library, the largest inEurope, and surrounded by smart city squares with cafes,restaurants and bars. It is within easy walking distance of the newBirmingham New Street station and a wide range of hotels.

Pre-Conference Courses (Sunday)

An industry approach to Bayesian phase I oncology trials:methodology and implementation - Simon Wandel, BeatNeuenschwander

Demystifying causal inference in randomised trials - Ian White,Graham Dunn, Sabine Landau, Richard Emsley

Network meta-analysis for decision making - David Phillippo,Sofia Dias

Analysis of single and multi-omic data (SNP array, geneexpression and methylation) and their integration in diseaseassociation studies - Juan R Gonzalez

Exploratory subgroup analyses in clinical trials - GerdRosenkranz

An introduction to the joint modelling of longitudinal andsurvival data, with applications in R - Dimitris Rizopoulos

If you have already registered for the conference but have not yetregistered for a course, please contact our Event ManagementTeam ([email protected]).

Mini-Symposium (Thursday)

Statistical methods in rare diseases and small populations

Strengthening Analytical Thinking for Observational Studies(STRATOS)

Students’ Day

Plenary Sessions (Monday & Wednesday):

On Monday, the ISCB President’s Invited Speaker, Diego Kuonen,will talk about ‘A Swiss Statistician’s “Big Tent” Overview of BigData and Data Science in Pharmaceutical Development’

On Wednesday, the conference Keynote Address will be deliveredby the esteemed David Spiegelhalter. His talk will be on ‘TheStatistics of Sex’.

Invited Sessions (Monday - Wednesday):

23 invited speakers will contribute to 7 special sessions selected bythe Scientific Programme Committee:

Statistical issues in stratified or personalised medicine andbiomarker discovery

Infectious disease epidemiology

Statistical methods in pharmaco-epidemiology and drug safety

Evidence synthesis and medical decision-making

Adaptive designs for oncology clinical trials

Research showcase from the MRC Network of Hubs for TrialsMethodology Research

Myths and pitfalls in survival analysis

Contributed Talks and Posters (Monday – Wednesday)

245 contributed talks and 200 posters available throughout theconference will cover topics ranging from observational studies toadaptive clinical trials and from small populations to big data.

Excursions (Tuesday)

Open Top Bus Tour of Birmingham and a chance to exploreWinterbourne House and Garden at the University

Visit to Stratford-upon-Avon, the birthplace of Shakespeare

Black Country Living Museum, one of the UK’s largest open-airmuseums, highlighting the industrial heritage of the local area

Malvern Hills Hike to see the beauty of the Worcestershire andHerefordshire countryside

Baddesley Clinton National Trust House and Garden, amedieval moated manor house

Social events

Student Gathering will be held on Sunday evening at a popularbar in the city centre

Welcome Reception will be held on Monday evening at theBirmingham Museum and Art Gallery.

Conference Dinner will be held on Wednesday evening at thefamous Edgbaston Cricket Ground with live music from TheSubterraneans

Need more information?

Please visit our website: www.iscb2016.info

Follow us on Twitter: @iscb2016

Email: [email protected]

Don’t miss the opportunity to join us in Birmingham for the firstISCB Conference in the UK since 2003.We look forward to seeing you!


ISCB37 Birmingham 2016: Conference Awards for Scientists: Winners

From Zdenek Valenta

In 2016, the ISCB National Groups Subcommittee (NatG SC) received a totalof 10 eligible applications for the Conference Awards for Scientists (CASc).The applications came from Bangladesh (2), Hungary (2), Nepal (2), Pakistan(1), Poland (2) and Turkey (1). The SC appears to be moving in the rightdirection by attracting the applications from mostly non-NatG countries.

All 12 NG SC members took part in the evaluation process this year whichwe believe contributed to an overall fairness of the selection process.

The SC members provided the assessment of each application by assigningthe grades between 1 and 5, with high scores reflecting excellence and lowones suggesting a rather poor quality of submission. The NatG SC memberswere also asked to express explicitly in words whether in their opinion thescientific contribution qualified the applicant for receiving the CASc award.

This year the National Groups Subcommittee decided to grant 3 ISCB CAScawards, listed below. The group of winning applicants achieved distinctivelyhigher total scores as compared to the remaining 7. This is why this year theSC had no problem in identifying the winning CASc applicants.

The 3 winning papers will be presented by their authors at contributedsections of the ISCB 2016 in Birmingham, UK. The winners are entitled toreceive free registration to the Birmingham Conference, freeaccommodation, one free short course of their choice, and attendance atthe Conference Dinner, as well as full travel support.

Congratulations to the 3 winners!

Name Country Title Session

Iveta Selingerová Czech Republic Kernel estimation as alternative to (semi)parametric models in survival analysis:simulated and real data

C13: Survival data analysis 4Mon 22 - 16:00

Iftakhar Alam Bangladesh A comparison between the continual reassessment method and D-optimum designfor dose finding in phase I clinical trials

C23: Early phase clinical trials 1Tue 23 - 09:00

Hasinur Khan Bangladesh On The Performance of Adaptive Pre-processing Technique in Analysing High-dimensional Censored Data

C33: Big data in healthcare 2Wed 24 - 09:00

ISCB37 Birmingham 2016: Student Conference Awards: Winners

From Nadine Binder

For the 2016 Annual Conference, we received 18 StCA applications: 2applications came from Australia, Belgium, Sri Lanka, and the UnitedKingdom; 1 application came from Canada, Czech Republic, France,Germany, Greece, India, Italy, Nigeria, Sweden, and The Netherlands.The sub-committee selected 3 students after a double-blind review ofthe submitted abstracts and summary papers from each applicant (listedbelow).

I would like to take the opportunity to thank the subcommittee forjudging the applications and for giving good care and deliberation in thedecision process. Thanks also to the President for valuable comments.

Reacting to last years’ accident that one application had not arrived inthe SC Chair’s email inbox. This year all applications were sent to boththe SC Chair and the SC Secretary. This worked smoothly and can easilybe continued in the future.

In addition, the subcommittee has taken actions for making the annualconferences a stimulating place with good networking opportunities for allyoung researchers. We established a young statisticians’ gathering during theconference in 2013, which has continued since and will take place at this years’conference on Sun 21 August – thanks to the LOC.

We furthermore developed a new event for the 2016 conference: TheStudents’ Day, which will take place on Thu 25 August. It comprisespresentations with advice from experienced researchers, but also contributionsfrom students, focussing on research methods, challenges and experiences.You may find the programme within this News.

Name Country University Title Session

Agnieszka Król France Bordeaux The use of tumor dynamics and non-target lesions to predict survival withmultivariate joint frailty models

C31: Survival data analysis 8Wed 24 - 09:00

ChristosThomadakis

Greece Athens Longitudinal and time-to-drop-out joint models can lead to seriously biasedestimates when the drop-out mechanism is at random

C34: Missing data 3Wed 24 - 09:00

Nicole Erler NetherlandsRotterdamBayesian imputation of time-varying covariates in linear mixed models C17: Missing data 2Mon 22 - 16:00

ISCB37 Birmingham 2016: Biometrical Journal Special Issue

From Nigel Stallard

The organisers of ISCB 2016 and the editors of Biometrical Journalintend to publish a selection of manuscripts of articles arising from theISCB 2016 in the Biometrical Journal as a special issue.

This Special Issue aims to publish on a fast track, high quality papers oncutting edge biostatistical methods for clinical research presented (orallyor as posters) at ISCB 2016. Although papers on any topic covered by theconference may be submitted to the special issue, papers areparticularly encouraged in the areas of Stratified and personalisedmedicine, Innovative clinical trial design, Survival data analysis andAdvances in statistical issues in epidemiology.

All papers will be subject to strict peer review according the rules of thejournal with an online publication scheduled for Sep 2017. The reviewprocess will be handled by the Special Issue guest editors: Nigel Stallard(University of Warwick, Chair of the Scientific Programme Committee),and three others to be determined.

Manuscript submission: The organisers of ISCB 2016 and the editors ofthe journal invite participants of the conference to be prepared tosubmit manuscripts as follows.

The submission of manuscripts will be handled through the website ofBiometrical Journal and the established electronic procedures. Please submityour manuscript to Manuscript Central. Indicate at Step 1 that the submissionis to a special issue and at Step 4 of the submission process enter "ISCB 2016"in the Special Issue Information field. You can submit you manuscript onlybetween 1 Sep and 1 Nov 2016.

Submitted manuscripts should fully comply with the Author Guidelines ofBiometrical Journal. It is recommended to use the style file of the journal andto adhere to the general aims and scope of Biometrical Journal as given in theInstructions to Authors (PDF).

Please note that the Biometrical Journal is devoted to Reproducible Research,details can be found on its website. Authors who intend to submit programs (Rlanguage and SAS preferred), original data sets and details of simulations areasked to indicate this already at submission and to download “ready to run”material such that in can be examined during the review process for thisSpecial Issue.

If you need any further information, please contact Nigel Stallard.


ISCB37 Birmingham 2016: Students’ Day

From Nadine Binder

This year, the Student Conference Awards subcommittee was pleased tooffer a new Students' Day on Thu 25 Aug. This day is open forregistration to recently graduated, ongoing or almost finished PhDstudents. The aim of the day is to stimulate discussion on how to shapea research career, e.g. on how to come up with competitive researchprojects.

Three experienced biostatistical researchers are going to give careeradvice on strategies for success in biostatistical research. A total of 14

students, ranging from just starting to almost finishing their PhD, will sharetheir ideas of doing good research and discuss research challenges they arefacing by means of their research projects. The detailed programme can befound below.

Registrations for the Student’s Day can be made through the conferenceregistration system. Participation is free for delegates already registered for theconference. We are looking forward to a stimulating exchange of experiences.

Draft Programme:(subject to changes)

09:00-09:15 Welcome

09:15-09:45 Robin Henderson Biostatistical Research Skills

Session 1 Challenges in clinical trials

09:45-10:00 Michael J Grayling Blinded and unblinded sample size re-estimation procedures for stepped wedge cluster randomised controlled trials

10:00-10:15 Caroline Kristunas A comparison of unequal cluster sizes in stepped-wedge cluster randomised trials

10:15-10:30 Jane Candlish Statistical design and analysis of proportionate intervention trials: a systematic review. Challenges in undertakingmethodological systematic reviews

10:30-10:45 Discussion

10:45-11:00 Refreshments

Session 2 Bayesian techniques

11:00-11:15 Gemma Clayton Quantitative, qualitative or both?

11:15-11:30 Davood RoshanSangachin

Adaptive Tolerance Range for Clinical Biomarkers using Bayesian Approaches

11:30-11:45 John Dennis Personalised medicine research in type 2 diabetes: study findings may be dependent on how response to a therapy isinitially defined

11:45-12:00 Laure Wynants Feeling stuck in research: lessons learned from studying heterogeneity in measures of clinical utility


12:15-13:15 Lunch

13:15-13:45 Katherine Lee Developing a Career in Biostatistics

Session 3 Longitudinal and time-to-event data

13:45-14:00 Stefan NygaardHansen

Estimating a cumulative incidence under calendar time trends

14:00-14:15 Morten Overgaard Jack-knife pseudo-observations and their use in regression analyses

14:15-14:30 Shivam Pandey Association of childhood head growth with adult systolic blood pressure: findings from the New Delhi Birth Cohort

14:30-14:45 Marie-Cécile Fournier The use of joint model for longitudinal and time-to-event data: an application on kidney transplantation


15:00-15:15 Refreshments

Session 4 Programming and simulation methods

15:15-15:30 Daniela Zöller Julia – a serious alternative to R for biostatisticians?

15:30-15:45 Tanja Berger Simulation study on the estimability of distribution parameters in the context of observations below the lower limitof quantification (LLOQ)

15:45-16:00 Julia Krzykalla Simulating high-dimensional molecular data


16:15-16:45 Hans vanHouwelingen

The Future of Biostatistics

16:45-17:00 Discussion and Farewell


ISCB37 Birmingham 2016: ISCB Annual General Meeting Agenda

From Vana Sypsa

The Annual General Meeting (AGM) will be held on Wednesday 24 August 2016 from 1200-1300 at the ISCB Conference Site, in the Plenary Hall.The draft agenda is the following:1 President's report2 Treasurer's report3 Subcommittee reports and motion for continuation:

3.1 Student Conference Awards3.2 Statistics in Regulatory Affairs3.3 National Groups3.4 Epidemiology3.5 Education3.6 Conference Organising

4 Update about future ISCB meetings:2017 Vigo and news about 2018+

5 Any Other BusinessNB Materials will be presented in summary form only to allow time for questions and discussion. For more detailed information, please see:http://www.iscb.info/Members-Area/AGM-2016-08-24-Birmingham.htmlALL participants of the ISCB meeting, including newcomers to ISCB are, by definition, ISCB members and are most welcome to attend the AGM. Please takepart and see what the Society does apart from the annual conference!

ISCB37 Birmingham 2016: Conf. Fund for Developing Countries (CFDC)

From Karla Hemming, KyungMann Kim and Koos Zwinderman

1. Announcement

In 2014, the ISCB Executive Committee approved a one-time budget of€15,000 to provide financial support to those from the developing countriesfor participation at the ISCB conference. This financial support is madeavailable only to those from the developing countries according to theWorld Bank List low and middle income countries, who submit an abstractfor either oral or poster presentation and are subsequently selected by theSPC for presentation.

After the ISCB36 in Utrecht in 2015, the Executive Committee decided toextend this funding scheme to ISCB37 in Birmingham in 2016. Theapplicants were to indicate their request for financial support at the time ofabstract submission with an application letter on the letterhead of theirinstitution of employment or study.

The selection for the award was based on the SPC’s determinationregarding the abstracts for oral/poster presentation. For the ISCB37 inBirmingham 2016, this was administered by the CFDC Subcommitteecomposed of Karla Hemming (ISCB37 LOC Member Liaison), KyungMann

Kim (ISCB Vice-President), and Koos Zwinderman (ISCB Past-President2015). The CFDC awardees were informed by Karla Hemming.

Funds can be used to defray the cost of travel/ accommodation/ annualconference registration fees. Up to €1,500 per participant was to beprovided if less than 10 winners are selected. Otherwise, €15,000 was to bedivided equally among the selected considering whether the applicationswere from Europe or from outside Europe.

The CFDC review process is separate from the Conference Award forScientists (CAS) administered by the NG Subcommittee and from theStudent Conference Awards (StCA) administered by the Student ConferenceAward Subcommittee. Those who applied for the CAS or the SCA and notselected were automatically considered for the CFDC support if theyqualified.

2. Implementation

This year there were 43 eligible applications, including those who hadapplied for the StCA or CASc awards but not selected. A selection had to bemade based on the SPC merit rating. The committee selected 10 applicantsfor the CFDC in travel/ accommodation/ annual conference registration fee.

3. Winners

Name Country Abstract title Session

Multilevel Modeling of Binary Outcome in Three Level Complex HealthSurvey Data

C46: Advances in statistical issues in epidemiology 3Wed 24 - 16:00

Adverse effect of tobacco use on pregnancy outcome: a multi-centerhospital based case control study in urban settings of Karachi, Pakistan

Poster: Analysis of observational studiesMon 22 - AM

Shafquat Rozi Pakistan

Predictors of smoking uptake in male adolescents attending public andprivate schools in Karachi, Pakistan: Multilevel modeling of survey data

Poster: Analysis of observational studiesWed 24 – AM

Nabil Awan Bangladesh A Post-stratification Approach for Efficient Estimation in Two-stageRandomized Clinical Trials

C12: Adaptive trial design and analysisMon 22 - 14.00

Havva Didem Ovla Turkey Investigation of Adjustment Techniques for Type I Error Rate Increased byMultiplicity in SNP Analyses

C28: Causal inference and mediation analysisTue 23 - 11.00

Vineet Kumar Kamal India A comparison of the hybrid CART-LOGIT model and tree based randomforest model for prognostication of patients with traumatic brain injury

C45: Analysis of observational studiesWed 24 - 16.00

Jayani Hapugoda Sri Lanka Joint Modeling of Survival and Count Variables: Joining the Discrete TimeHazard model with the Poisson Regression model

C35: Inference in infectious diseasesWed 24 - 09.00

Sunethra AbeysingheArachchige

Sri Lanka A novel approach for jointly modeling survival times and recurrentepisodes of disease progression

C19: Survival data analysisTue 23 - 09.00

Shaila Sharmin Bangladesh Analysis of Unobserved Heterogeneity Incorporated with AcceleratedFailure Time Models: Bayesian versus Classical

C01: Survival data analysisMon 22 - 11.00

An application of the latent class modelling to predict risk of mortalityamong cases of acute poisoning

C45: Analysis of observational studiesWed 24 - 16.00

Kashif Shafique Pakistan

Complex measures of health inequalities for family planning methodsamong women: Demographic and health survey data

Poster: Analysis of observational studiesMon 22 - AM

Ozgur Asar Turkey Early detection of patients with high risk of developing end-stage renaldisease in primary care

C47: Longitudinal data analysisWed 24 - 16.00

Khanal ShankarPrasad

Nepal Comparison of Cox Proportional Hazards Model and Accelerated FailureTime Models in the Survival of Acute Liver Failure Patients

Poster: Survival data analysisWed 24 PM

ISCB37 Birmingham, UK: 21-25 August 2016: Draft Programme


Overview 1:see also http://www.birmingham.ac.uk/facilities/mds-cpd/conferences/iscb-2016/programme/programme.aspx

From To Sun 21 Aug Mon 22 Aug Tue 23 Aug Wed 24 Aug Thu 25 Aug

09:00 09:30 Welcome, Introduction

09:30 10:00

10:00 10:30

President's Invited Speaker:Diego Kuonen

I4: Evidencesynthesis and

medical decision-making

C19-C24

I6: Research showcasefrom the MRC Network of

Hubs for TrialsMethodology Research

C31-C36

MS1: Statisticalmethods in rare

diseases and smallpopulations

MS2: Strengtheninganalytical thinking forobservational studies

(STRATOS)

Students' Day

10:30 11:00

Courses 1-5

Refreshments Refreshments Refreshments Refreshments

11:00 11:30 Refreshments

11:30 12:00

Keynote Speaker:David Spiegelhalter

12:00 12:30

I1: Statistical issues instratified or personalisedmedicine and biomarker

discovery

C01-C06

I5: Adaptivedesigns for

oncology clinicaltrials

C25-C30

MS1 (cont) MS2 (cont) Students' Day(cont)

12:30 13:00

continued

lunch

ISCB Annual General Meeting

13:00 13:30

lunch

13:30 14:00

lunch

lunch

lunch

14:00 14:30

14:30 15:00

MS1 (cont) Students' Day(cont)

15:00 15:30

Courses 1-4(cont)

Course 6

I2: Infectious diseaseepidemiology

C07-C12

I7: Myths and pitfalls insurvival analysis

C37-C42

MS2 (cont)

Refreshments

15:30 16:00 Refreshments Refreshments Refreshments

16:00 16:30

16:30 17:00

Students' Day(cont)

17:00 17:30

continued I3: Statistical methods inpharmaco-epidemiology

and drug safety

C13-C18

Conference Excursions(pre-paid tickets only)

C43-C49

17:30 18:00

18:00 18:30

18:30 19:00

19:00 StudentGathering

Welcome Reception at BirminghamMuseum and Art Gallery(pre-booked tickets only)

Conference Dinner at EdgbastonStadium (pre-paid tickets only)



Overview 2:

From To Plenary

Sun 21 Aug

08:00 09:30

09:30 11:00 PCC1:An industry approach toBayesian phase Ioncology trials:methodology andimplementation

PCC2:Demystifying causalinference in randomisedtrials

PCC3:Network meta-analysisfor decision-making

PCC4:Analysis of single andmulti-omic data (SNP array,gene expression andmethylation) and theirintegration in diseaseassociation studies

PCC5:Exploratory subgroup analyses in clinical trials


11:30 13:00 PCC1: (cont) PCC2:(cont) PCC3: (cont) PCC4: (cont) PCC5: (cont)

13:00 14:00 Lunch

14:00 15:30 PCC1: (cont) PCC2:(cont) PCC3: (cont) PCC4: (cont) PCC6:An introduction to the joint modelling of longitudinal andsurvival data, with applications in R


16:00 17:30 PCC1: (cont) PCC2: (cont) PCC3: (cont) PCC4: (cont) PCC6: (cont)

17:30 19:00

19.00 Student Gathering

Mon 22 Aug

08:00 09:00

09:00 09:30 Welcome andIntroduction:

Cindy Billingham, LOC Chair, Nigel Stallard, SPC ChairDavid Adams, Pro-Vice-Chancellor, Head of College of Medical and Dental Sciences and Dean of Medicine, University of BirminghamDavid Warne, ISCB President

09:30 10:30 President's InvitedSpeaker:

Diego Kuonen: "A Swiss Statistician’s “Big Tent” Overview of Big Data and Data Science in Pharmaceutical Development"

10:30 11:00 Refreshments and Posters

11:00 12:30 I1: Statistical issues instratified or personalisedmedicine and biomarkerdiscovery

C1 Survival data analysis1

C2 Meta analysis andmedical decision making1

C3 Advances instatistical issues inepidemiology 1

C4 Cluster randomisedand stepped wedgetrials 1

C5 Missing data 1 C6 Other 1

12:30 14:00 Lunch and Posters

14:00 15:30 I2: Infectious diseaseepidemiology



C9 Statistics in rarediseases and smallpopulations 1


C11 Stratified andpersonalised medicine 1

C12 Adaptive trial designand analysis 1


16:00 17:30 I3: Statistical methodsin pharmaco-epidemiology and drugsafety

C13 Survival dataanalysis 4




C17 Missing data 2 C18 Analysis ofobservational studies 1

17:30 19:00

19.00 Welcome Reception at Birmingham Museum and Art Gallery (pre-booked tickets only)



Tue 23 Aug

08:00 09:00

09:00 10:30 I4: Evidence synthesisand medical decision-making




C22 Analysis ofobservational studies 2

C23 Early phase clinicaltrials 1

C24 Other 2


11:00 12:30 I5: Adaptive designs foroncology clinical trials



C27 Cluster randomisedand stepped wedgetrials 2

C28 Causal inferenceand mediation analysis 1

C29 Longitudinal dataanalysis 1

C30 Big data inhealthcare 1

12:30 13:00 Lunch (Packed Lunch)

13:00 Conference Excursions (pre-paid tickets only)

Wed 24 Aug

08:00 09:00

09:00 10:30 I6: Research showcasefrom the MRC Network ofHubs for TrialsMethodology Research



C33 Big data inhealthcare 2

C34 Missing data 3 C35 Inference ininfectious diseases

C36 Other 3


11:00 12:00 Keynote Speaker: David Spiegelhalter: The Statistics of Sex

12:00 13:00 ISCB Annual General Meeting

13:00 14:00 Lunch and Posters

14:00 15:30 I7: Myths and pitfalls insurvival analysis



C39 Cluster randomisedand stepped wedge trials 3


C41 Advances in statisticalissues in epidemiology 2

C42 Causal inferenceand mediation analysis 2


16:00 17:30 C43 Survival dataanalysis 9

C44 Early phase clinicaltrials 2


C46 Advances in statisticalissues in epidemiology 3

C47 Longitudinal dataanalysis 2

C48 Diagnostic tests C49 Other 4

17:30 19:00

19:00 Conference Dinner at Edgbaston Stadium (pre-paid tickets only)

Thu 25 Aug

08:00 09:00

09:00 09:30

09:30 10:30 MS1: Statistical methods inrare diseases and smallpopulations

MS2: Strengtheninganalytical thinking forobservational studies(STRATOS)

Students' Day



11:00 12:15 MS1 (cont) MS2 (cont) Students' Day (cont)

12:15 12:30 Lunch

12:30 13:15 Lunch Lunch

13:15 14:00 1330: MS1 (cont) Students' Day (cont)

14:00 15:00 MS2 (cont)


15:15 15:30 Students' Day (cont)

15:30 17:00



Details:Sun 21 Aug

09:30-17:30PCC1: An industry approach toBayesian phase I oncology trials:methodology and implementation

SimonWandel,BeatNeuenschwander,Basel,Switzerland

09:30-17:30PCC2: Demystifying causal inference inrandomised trials

Ian White,Cambridge,UK,GrahamDunn,Manchester,UK,SabineLandau,London, UK,RichardEmsley,Manchester,UK

09:30-17:30PCC3: Network meta-analysis fordecision-making

DavidPhillippo,Sofia Dias,Bristol, UK

09:30-17:30PCC4: Analysis of single and multi-omicdata (SNP array, gene expression andmethylation) and their integration indisease association studies

Juan RGonzalez,Barcelona,Spain

09:30-13:00PCC5: Exploratory subgroup analysesin clinical trials

GerdRosenkranz,Basel,Switzerland

14:00-17:30PCC6: An introduction to the jointmodelling of longitudinal and survivaldata, with applications in R

DimitrisRizopoulos,Rotterdam,Netherlands

Mon 22 Aug

09.00-09.30Welcome and Introduction

09.30-10.30President's Invited Speaker

A Swiss Statistician’s “Big Tent”Overview of Big Data and Data Sciencein Pharmaceutical Development

DiegoKuonen,StatooConsulting,Switzerland

Mon 22 Aug

11:00-12:30I1 Statistical issues in stratified orpersonalised medicine and biomarkerdiscovery

Applied systems medicine for therapyprediction and clinical trial design inpersonalized oncology

FrederickKlauschen,Charité -UniversitätsmedizinBerlin,Germany

Methods for integrated analysis ofomics datasets: prediction and biology

JeanineHouwing-Duistermaat, Universityof Leeds,UK

Adaptive enrichment designs NigelStallard,WarwickMedicalSchool,University ofWarwick,UK

11:00-12:30C1 Survival data analysis 1

Using the PP-plot Area Test and aDivergence Measure for ImprovedSurvival Analyses Within Clinical Trials

Trevor Cox

On the use of net survival methods forpopulation-based studies in clinicaltrials to correct misspecificationproblem and selection effect.

Goungounga Juste

The impact of selection andchronological bias on test decisions insurvival analysis

MarciaRückbeil

Analysis of Unobserved HeterogeneityIncorporated with Accelerated FailureTime Models: Bayesian versus Classical

ShailaSharmin

Approximate Bayesian methods in curesurvival models: Coupling P-splineswith Laplace approximations for fastinference.

OswaldoGressani

Mon 22 Aug

11:00-12:30C2 Meta analysis and medical decisionmaking 1

Meta-analysis using individualparticipant data: 10 reasons why one-stage and two-stage models may givedifferent results

DanielleBurke

Derivation of percentage study weightsin one-stage and two-stage individualparticipant data meta-analysis models

RichardRiley

Comparison of bivariate methods formeta-analysis of diagnostic testaccuracy studies with individual patientdata

ChristopherPartlett

Individual participant data meta-analysis for external validation andrecalibration of a prognostic model

J. Ensor

One Stage Meta-analysis of JointLongitudinal and Time-to-EventOutcomes

Maria Sudell

11:00-12:30C3 Advances in statistical issues inepidemiology 1

Age-at-onset subsets of bipolar Idisorders: a critical insight intoadmixture analyses

Clairemontlahuc

Using family relationships to improveconsistency of identification ofAboriginal people in linkedadministrative data

AlisonGibberd

Multi-way interaction among binary riskfactors on the additive scale

MichailKatsoulis

Testing for centre effects on hospitalmortality in ICU patients withhematologic malignancies usingpermutation tests

Lucie Biard

Investigating the assumptions neededwhen imputing missing diseaseinformation due to death in cohortstudies with discrete follow-up visits

NadineBinder



Mon 22 Aug

11:00-12:30C4 Cluster randomised and steppedwedge trials 1

Modeling differential clustering andtreatment effect heterogeneity inparallel and stepped wedge clustertrials

KarlaHemming

The Implications of DifferentialClustering for the Analysis of ClusterRandomised Trials with a BinaryOutcome

ChrisRoberts

Impact of non-uniform correlationstructure in multiple-period clusterrandomised trials

AndrewForbes

The design of cluster randomized trialswith random cross-classifications

MirjamMoerbeek

Spatial Regression and Spillover Effectsin Cluster Randomized Trials

NealAlexander

11:00-12:30C5 Missing data 1

Imputation of systematically andpartially missing predictors in individualparticipant data (IPD) meta-analysis

ShahabJolani

Statistical methods for the ExtremePhenotype Sampling design

TheaBjørnland

A sparse factor model approach toanalysis of high dimensional data withmissing covariate

Soeun Kim

Analysing correlated multiple outcomesmeasures using multivariate models.

VictoriaVickerstaff

Cox regression model with an intervalcensored binary time-varying covariate

Yang-j Kim

11:00-12:30C6 Other 1

A comparison of shrinkage anticipationand correction in Cox regression

MichaelKammer

Confidence Bands for the MeanResidual Life function

AmirhosseinJalali

Modeling agreement between two fixedscorers on a bounded scale

SophieVanbelle

Analysis of multivariate longitudinalordinal endpoints: neurologists borrowfrom social statistics

LorenzoTanadini

Non-Concave Penalized Log-Likelihoodin Linear Mixed-Effect Models and theRegularized Selection of Fixed Effects

Abhik Ghosh

Mon 22 Aug

14:00-15:30I2 Infectious disease epidemiology

Statistical Methods for real-timemonitoring of health outcomes

PeterDiggle,Liverpool/Lancaster

Inferring time-dependent basicreproduction numbers from serialseroprevalence data on hepatitis A

Neil Hens,Hasselt

Outbreak analysis and modelling: theZika challenge

ChristlDonnelly,ImperialCollege,London


On the improvement of predictionaccuracy for survival models

MaralSaadati

Effect of non-proportionality of thehazard ratio in sample size estimationand its relationship with othermeasures.

MoisésGómezMateu

Estimation of net survival with pseudoobservations

KlemenPavlic

Cox Regression for Doubly TruncatedData

MichaMandel

The statistical analysis of recurrentevent processes subject to interval-censoring and resolution

Hua Shen

14:00-15:30C8 Survival data analysis 3Parametric multi-state survival models:flexible modelling allowing transition-specificdistributions with application to estimatingclinically useful measures of effectdifferences

MichaelCrowther

Motivating multistate modeling ofrecurrent composite endpoints inrandomized cardiovascular trials viabias analyses with directed acyclicgraphs

Antje Jahn

Multi-state models for cardiovasculardisease

FrancescaGasperoni

Estimation of transition probabilities innon-Markov multi-state models

Hein Putter

Nonparametric estimation for multi-state models under cross-sectionalsampling

Jacobo deUña-Álvarez

Mon 22 Aug

14:00-15:30C9 Statistics in rare diseases and smallpopulations 1

Efficient tests to demonstrate thesimilarity of dose response curves withregard to small sample sizes

KathrinMöllenhoff

A Selection Bias AdjustedRandomization Test

DianeUschner

A framework for scientific evaluation ofrandomization procedures in smallclinical trials

Ralf-DieterHilgers

Assessment of randomizationprocedures with respect to multipleobjectives

DavidSchindler

N-of 1 trials, Statistical Inference &Rare Diseases

StephenSenn


Inconsistency in network meta-analysis: a critical comparison ofmethods

SuzanneFreeman

Two new methods to fit models fornetwork meta-analysis with randominconsistency effects

Martin Law

Network meta-analysis for theintegrated evaluation of targetedtherapies with binary outcomes

TanjaProctor

Quantifying the Effects of Bias:Decision-Invariant Bias Intervals forBayesian Network Meta-Analysis

David M.Phillippo

Incorporating external information onbetween-study heterogeneity innetwork meta-analysis

RebeccaTurner



Mon 22 Aug

14:00-15:30C11 Stratified or personalised medicineand biomarker discovery 1

Group Sequential Designs andBiomarker Decision Making - SimilarBut Different

ChrisHarbron

A novel adaptive biomarker enrichmentclinical trial design for time-to-eventoutcomes

DeepakParashar

Do targeted clinical trials profit fromthe inclusion of biomarker-negativepatients?

ChristinaBeisel

A Design for Phase II Clinical Trials inStratified Medicine with Efficacy andToxicity Outcomes and PredictiveVariables

KristianBrock

Current biomarker-guided clinical trialdesigns: a comparison of statisticalcharacteristics

MirantaAntoniou

14:00-15:30C12 Adaptive trial design and analysis1

Using an equivalence weight approachto incorporate historical control data inthe design of a new trial

MaxineBennett

Quantifying the estimated treatmenteffect in trials planning interimanalyses with potential early stoppingfor futility.

StephenWalter

A Post-stratification Approach forEfficient Estimation in Two-stageRandomized Clinical Trials

Nabil Awan

Correcting for selection bias andcorrelation in time-to-event analysis inadaptive designs

JosephineKhan

Point and interval estimation forconfirmatory two-stage adaptive trialswith multiple endpoints

PeterKimani

Mon 22 Aug

16:00-17:30I3 Statistical methods inpharmacoepidemiology and drug safety

The self-controlled case series method:introduction and investigating theassumptions

HeatherWhitaker,The OpenUniversity

The emerging and merging fields ofbenefit-risk and health technologyassessments

Shahrul Mt-Isa, MerckSharp &Dohme

Pharmacoepidemiology: rightquestions? right answers?

StephenEvans andElizabethWilliamson,LondonSchool ofHygiene andTropicalMedicine


Stabilised Aalen-Johansen estimator ofthe transition probabilities to protectagainst too small risk sets

ArthurAllignol

Non-parametric simulation and a novelwild bootstrap resampling procedurefor the multistate Aalen-Johansenestimator

TobiasBluhmki

Kernel estimation as alternativeto(semi)parametric models in survivalanalysis: simulated and real data

IvetaSelingerova[CAScwinner]

On the maximum penalised likelihoodapproach for semiparametricproportional hazard models witharbitrary censoring

Dominique-LaurentCouturier

Translational Statistics in Time to EventStudies

John Newell

Mon 22 Aug


A unified competing risks modellingusing mixture distributions

Jun Ma

Investigating hospital heterogeneitywith a competing risks frailty model

AnjaRueten-Budde

Analysis of interval censored failuretime data with competing risk

Yang-JinKim

Multiple imputation for missingcovariate data in stratified cause-specific hazards models

MichaelLauseker

Interpretation of effect estimates incompeting risks survival models: Asimulated analysis of organ-specificprogression-free survival in arandomised phase III cancer trial

PradeepVirdee


Artificial Neural Networks SurvivalModel for Predicting Outcomes ofGastric Cancer Patients in Presences ofCensored data

HamidNilsazDezfouli

Optimism bias correction in omicstudies: assessment of penalizedmethods on simulated data

Pascal Roy

Using multiple biomarkers to informpersonalised treamtentrecommendations

MatthiasPierce

Simultaneous confidence intervals fortreatment effects in subgroups inbiomarker stratified designs

Fang Wan

Why don't we all lose weight equallyon Low Calorie Diet? Proteomicsexplanation to weight loss variability inoverweight and obese subjects

IrinaIrincheeva



Mon 22 Aug

16:00-17:30C16 Adaptive trial design and analysis2Accurate and powerful p-values for adaptivedesigns with binary endpoints

StephaneHeritier

Extending a running exploratory time-to-event trial into a confirmatory trial

Ute vonWangenheim

Practical challenges of running adaptivetrials in an academic trials unit

Jane Holmes

Adaptive Designs in clinical trials fromScientific Advice to Marketing Authorisation:lessons learnt from submissions to theEuropean Medicines Agency

OlivierCollignon

Response-Adaptive Randomization andAdaptive Design in Small Population ClinicalTrials: Pitfalls and Advantages

Franz König

16:00-17:30C17 Missing data 2Comparison of multiple imputation methodsfor systematically and sporadically missingmultilevel data

VincentAudigier

Multiple Imputation of cross-classifiedmultilevel models

ShahabJolani

Reference based sensitivity analysis forclinical trials with missing data via multipleimputation: Investigation of Rubin'svariance estimate

Suzie Cro

Applying multiple imputation to multi-itempatient reported outcome measures:advantages and disadvantages of imputingat the item, sub-scale or score level

InesRombach

Bayesian imputation of time varyingcovariates in linear mixed models

Nicole Erler[StCA winner]

Mon 22 Aug

16:00-17:30C18 Analysis of observational studies 1Propensity score methods in the estimationof treatment effect modification inobservational studies

AntoniaMarsden

Propensity score matching to support thecomparison between patients with andwithout treatment switch in a randomizedtrial on chronic myeloid leukaemia

MarkusPfirrmann

Propensity score methods versus covariateadjustment - a practical evaluation in fourcardiovascular cohort studies

John Gregson

Propensity score analysis with partiallyobserved confounders: how to use multipleimputation?

ClémenceLeyrat

More efficient methods to take into accountPrognostic Scores in observational studies

David Hajage

Tue 23 Aug

09:00-10:30I4 Evidence synthesis and medicaldecision-makingDecision making under alternativeinterpretations of the evidence

TomTrikalinos,BrownUniversity,ProvidenceRI, USA

Complex evidence syntheses to inform NICEclinical guidelines

Sofia Dias,University ofBristol, UK

Meta-analysis of prediction modelsand decision making

EwoutSteyerberg,Erasmus MC,Rotterdam,Netherlands

09:00-10:30C19 Survival data analysis 6Using dynamic prediction to inform theoptimal intervention time for individuals inan abdominal aortic aneurysm screeningprogramme

MichaelSweeting

Multiple imputation of time-dependentcovariates in survival analysis: Two-stagejoint model with multiple continuousmarkers

MargaritaMoreno-Betancur

Extension of the association structure injoint models to include weighted cumulativeeffects

Katya Mauff

A novel approach for jointly modelingsurvival times and recurrent episodes ofdisease progression

SunethraAbeysingheArachchige

Joint Modelling Approach for Longitudinaland Competing-Risks Data via H-likelihood

IL DO HA

09:00-10:30C20 Stratified or personalised medicineand biomarker discovery 3A statistical framework for using externalinformation in updating prediction modelswith new biomarkers

Jeremy Taylor

The Wally plot approach to assess thecalibration of prediction models

Paul Blanche

treatment selection markers: benefitfunctions, marker-selections & indicationbias

KoosZwinderman

Reporting of prognostic tumour markerstudies after the introduction of theREMARK guideline needs improvement

Sue Mallett

Diagnostic Method for Optimal PersonalizedTreatment Rules

Xin Qiu

Tue 23 Aug

09:00-10:30C21 Statistics in rare diseases andsmall populations 2Multi-armed platform trials in smallpopulations using a two-step testingprocedure incorporating efficacy and safety

Gerald Hlavin

Optimal exact tests for multiple binaryendpoints

Robin Ristl

Using re-randomisation make randomisedtrials in rare diseases more feasible

BrennanKahan

Implementation of a flexible trial design inrelapsed Ewing’s sarcoma

VeronicaMoroz

Rare events bias of logistic regression Rok Blagus

09:00-10:30C22 Analysis of observational studies 2

Guidelines for the use and presentationof funnel plots

IlonaVerburg

Causal diagrams, expert opinion andstructure learning: vetting the expert

JessicaKasza

Instrumental Variable Estimation Underthe Semiparametric Accelerated FailureTime Model

MenggangYu

Comparing approaches for ConfoundingAdjustment in Secondary DatabaseAnalyses: High-Dimensional PropensityScore versus two machine learningalgorithms: Random Forest and Elastic Net

MohammadEhsanulKarim

Use of the prevented fraction to estimatethe number of cases of stroke that can beavoided by using lipid lowering drugs in theFrench Three-City cohort

MalamineGassama

09:00-10:30C23 Early phase clinical trials 1A comparison between the continualreassessment method and D-optimumdesign for dose finding in phase I clinicaltrials

M. IftakharAlam[CAScwinner]

A method for dose-finding based on aweighted differential entropy that does notrequire a monotonicity assumption

PavelMozgunov

A Bayesian decision-theoretic approach toincorporating pre-clinical information intophase I clinical trials

Haiyan Zheng

Adapted Bayesian design for Phase I/IIclinical trials

Yuh-Ing Chen

Simulation-based adjustment forexploratory biomarker subgroupselection in phase II

Heiko Götte



Tue 23 Aug

09:00-10:30C24 Other 2

Recommendations on multiple-testingadjustment in multi-arm trials withcorrelated hypotheses

DenaHoward

Using emerging trial data to updatecost effectiveness decision models

BenjaminThorpe

tSNR as Variable Selection Techniquein Genome-Wide Data Analysis

Nazatulshima Hassan

The efficient choice of a primary binaryendpoint for sample size assessment

Marta BofillRoig

Type I error and power for detectinghospitals with high or low 30-daymortality.

Doris ToveKristoffersen

11:00-12:30I5 Adaptive designs for oncologyclinical trials

Bayesian Adaptive Trial Design WithMultiple Efficacy Endpoints forHeterogeneous Subpopulations

LindsayRenfro,Mayo Clinic,US

Design and implementation of platformtrials for biomarker-driven questions

MatthewSydes, MRCCTU at UCL,London, UK

A Decision Theoretic Approach toOptimize Clinical Trial Designs forTargeted Therapies

Martin Posch,MedicalUniversity ofVienna


Parametric Estimation of SurvivalDistributions in Two-StageRandomization Designs

SifisoVilakati

Direct likelihood inference on the cause-specific cumulative incidence function: aflexible parametric subdistribution hazardsregression model

SarwarIslam

Flexible assessment of non-linearcovariate effects in a pseudo-valueregression model

UlrikePötschger

Incorporating the time-dependency inROC methodology for censored clinicalevent

Adina NajwaKamarudin

Can methods incorporating repeat biologicalmeasurements improve cardiovascular riskprediction?

JessicaBarrett

Tue 23 Aug


When should we use multivariatemeta-analysis? Predictors of Borrowingof Strength in 43 bivariate meta-analyses within Cochrane

MiriamMacDonald

Investigating the extent ofheterogeneity due to studycharacteristics in meta-analysis

KirstyRhodes

Bayesian Predictive Power: Choice ofPrior and some implications

KasparRufibach

Meta-analysis of standardised meandifferences from randomised trials withtreatment-related clustering

RebeccaWalwyn

The albatross plot: a novel graphicaltool for presenting results of diverselyreported studies in a systematic review

SeanHarrison

11:00-12:30C27 Cluster randomised and steppedwedge trials 2

Stepped wedge cluster randomisedtrials: a review of the statisticalmethodology used .

MichaelCampbell

Stepped-Wedge design effects whenthe clusters are not equal in size

Alan Girling

Estimability and bias of the treatment effectin a classical cohort stepped wedge designunder consideration of carry-over effectsand autoregressive covariance structure.

AnnChristinaFoldenauer

Accounting for time in mixed effectsmodels in a stepped wedge clusterrandomised trial design

AleciaNickless

Sample size calculations for a SteppedWedge Cluster Randomised Trial mustconsisder the impact of adjusting fortime

PatrickMcElduff

Tue 23 Aug

11:00-12:30C28 Causal inference and mediationanalysis 1Adjusting for bias in unblinded randomizedcontrolled trials.

AmandSchmidt

Using marginal structural models toestimate direct and indirect effects incluster randomised trials

GordonForbes

Investigation of AdjustmentTechniques for Type I Error RateIncreased by Multiplicity in SNPAnalyses

HavvaDidem Ovla

Constant effect assumption versusindividualized medicine

Erik Cobo

Causal Inference under Selection VanessaDidelez

11:00-12:30C29 Longitudinal data analysis 1

Bayesian Inference for a Joint Model ofMultiple Longitudinal Measures andMultiple Recurrent Events

SamuelManda

Utilising the Coxian phase-type distributionto represent patient survival within a jointmodelling framework

ConorDonnelly

Marginal quantile regression with aworking association matrix

DavideBossoli

Comparison of a flexible complex and asimple discriminant analysisapproaches for longitudinally collecteddata

Riham Elsaeiti

Permuting longitudinal data despite allthe dependencies

SarahFriedrich

11:00-12:30C30 Big data in healthcare 1

Identifying potentially interestingcovariates for genetic risk scores underdata protection constraints in consortia

DanielaZöller

Regularized redundancy analysis forhigh dimensional data

Michel Hof

Comparison of em and two-step clustermethod for mixed data: an application

Ozge Pasin

OLS versus quantile regressions fromtiny to big data: application toelectrocardiography data.

Bernard GFrancq

Statistical methods to compare NextGeneration Sequencing Pipelines

Pascal Roy



Wed 24 Aug

09:00-10:30I6 Research showcase from the MRCNetwork of Hubs for TrialsMethodology Research

The MRC Hubs for Trials MethodologyNetwork: Improving health byimproving trials

Jane Blazeby,School ofCommunityMedicine,

Implementation of an adaptive, model-based dose-finding design in anoncology trial

Christina Yap,CancerResearch UKClinical TrialsUnit,UniversityBirmingham,UK

TAILoR: Lessons from a multi-armmulti-stage clinical trial in HIV/AIDS

Thomas Jaki,LancasterUniversity, UK

Laying the groundwork for a trial:biomarker identification

AndreaJorgensen,University ofLiverpool, UK

Novel designs for trials with multipletreatments and biomarkers

JamesWason, MRCBiostatisticsUnit,Cambridge,UK


Pre-test estimation in the illness-deathmodel

MarRodríguez-Girondo

The use of tumor dynamics and non-target lesions to predict survival withmultivariate joint frailty models

AgnieszkaKrol[StCAwinner]

Explained variation in shared frailtymodels for multi-center studies ofsurvival

AndreasGleiss

Assessing impact of center on survivaloutcomes in the presence of missingdata

Liesbeth deWreede

Dynamic prediction of time topregnancy leading to live birth incouples with unexplained reasons fortheir infertility

DavidMcLernon

Wed 24 Aug

09:00-10:30C32 Analysis of observational studies 3An application of model-fitting for marginalstructural modeling in the context of a raredisease observational cohort study withmissing exposures

Hyang Kim

Improving prognostic accuracy when usinglongitudinal biomarkers from multiplesources

Marta Garcia-Finana

General linear models for investigating theassociation between gene module co-expression and a continuous trait

TrishantaPadayachee

A tool for identification of familial colorectalcancer risk

Anna Rieger

Combining clinical and omics data toconstruct a predictor and assess itspredictive value – comparison of severalstrategies

WilliSauerbrei

09:00-10:30C33 Big data in healthcare 2On The Performance of Adaptive Pre-processing Technique in Analysing High-dimensional Censored Data

HasinurRahaman Khan[CASc winner]

External validation of clinical predictionmodels using big data from e-health recordsor IPD meta-analysis

Richard Riley

Robust classification of high dimensionaldata in health care

Anna MariaPaganoni

Selecting a predictive function for survivalanalysis with gene expression data

Victor L. Jong

Use of time varying propensity scores to mimicproperties of randomised controlled trials:evaluating the effect of allopurinol in gout usingthe Clinical Practice Research Datalink

TrishnaRathod

09:00-10:30C34 Missing data 3A causal modelling framework for the defacto estimand in clinical trials with noobservation after treatment dropout

Royes Joseph

Conducting sensitivity analyses todepartures from MAR in the multipleimputation framework using the Not atRandom Fully Conditional Specificationprocedure

Finbarr Leacy

Developing a sensitivity analysis frameworkfor addressing informative missingness inthe analysis of clinical trials

AlexinaMason

Longitudinal and time-to-drop-out jointmodels can lead to seriously biasedestimates when the drop-out mechanism isat random

ChristosThomadakis[StCA winner]

Randomization based Inference - How todeal with missing observations

NicoleHeussen

Wed 24 Aug

09:00-10:30C35 Inference in infectious diseasesEstimation of covariate effect on serologicalresponse rate based on bivariate interval-censored measurements

Yin BunCheung

A Bayesian SEIR model with nonparametricdisease transmission rate to analyse thepropagation of Ebola in Sierra Leone

PhilippeLambert

Inference in a stochastic SEIR epidemicmodel using Sequential Monte Carlomethods

WilfriedBonou

Joint Modeling of Survival and CountVariables: Joining the Discrete Time Hazardmodel with the Poisson Regression model

Jayani (J.C.)Hapugoda

Stochastic simulations for HIV spreading inhyperendemic settings

StéphanieBlaizot

09:00-10:30C36 Other 3

Robust bivariate meta-analytic-predictive priors for including historicalinformation on control rates andtreatment effects in paediatric clinicaltrials

ClaraDominguezIslas

New correlated-errors-in-variablesregressions in method comparisonstudies.

Bernard GFrancq

A recursive partitioning approach forsubgroup identification in individualpatient data meta-analysis

DipeshMistry

How European regulators deal withsubgroups during the procedure ofobtaining a Marketing AuthorisationApplication

JulienTanniou

Tubular quantile and expectile contoursStenWillemsen

11:00-12:00Keynote Lecture

The statistics of sex DavidSpiegelhalter,University ofCambridge,UK

12:00-13:00ISCB Annual General Meeting All!



Wed 24 Aug

14:00-15:30I7 Myths and pitfalls in survivalanalysis

Prevalent cohort studies andunobserved heterogeneity

Neils Keiding,Departmentof PublicHealth,Section ofBiostatistics,University ofCopenhagen,Denmark

The elusive concept of frailty: Aglimpse into survival, heterogeneityand causality

Odd O. Aalen,DepartmentofBiostatistics,Institute ofBasic MedicalSciences,University ofOslo, Norway

Competing risks, immortal time bias:two myths in survival analysis?

JanBeyersmann,Institute ofStatistics,UlmUniversity,Germany


Incorporating the time in ROCmethodology for better medicaldecision making

RuwanthiKolamunnage-Dona

Spatial mixed-effect modelling fornovel imaging biomarkers of malarialretinopathy from a clinicalobservational study

GabrielaCzanner

Choosing the number of classes inBayesian finite mixture models usingthe posterior distribution ofthe mixing proportions

Joost vanRosmalen

A Prediction predictive model for riskstratification of cognitative impairmentpost stroke

MarionFahey

Instrumental variable methods forexploring mechanisms in stratifiedmedicine

RichardEmsley

Wed 24 Aug

14:00-15:30C38 Adaptive trial design and analysis3Optimal group sequential tests for delayedresponses with non-binding futilityboundaries

Lisa Hampson

Interim analyses incorporating short- andlong-term endpoints for binary correlatedoutcomes

JuliaNiewczas

Bayesian stopping rules for binary-endpointtrials

Vincent vander Noort

Bayesian Hierarchical Classification andInformation Sharing for Clinical Trials WithSubgroups and Binary Outcomes

J. Jack Lee

Performance of Subgroup Selection Rules inAdaptive Oncology Trials with Time-to-eventOutcome

JohannesKrisam

14:00-15:30C39 Cluster randomised and steppedwedge trials 3Optimal design of cluster randomised trialswith baseline data

AndrewCopas

Choosing a two-stage design for a clusterrandomised trial with one-way cross-over:the benefits of incompleteness

RichardHooper

Missing binary outcomes under covariatedependent missingness in clusterrandomised trials

AnowerHossain

Linked cluster-randomised trials of complexinterventions: A "split-block" design

RebeccaWalwyn

Split-plot designs in healthcare: an overview BeatrizGoulao

14:00-15:30C40 Statistics in rare diseases andsmall populations 3

Predictive performance of multinomiallogistic prediction models - a simulationstudy

Valentijn deJong

Meta-analysis of two studies in thepresence of heterogeneity withapplications in rare diseases

ChristianRöver

Dynamic borrowing through empiricalpower priors that control type I error

StavrosNikolakopoulos

Performance of heterogeneityestimators under a sparse - eventsmeta analysis in small populations.

Konstantinos Pateras

Clinical drug development in epilepsyrevisited: a proposal for a new paradigmstreamlined using extrapolation

IanWadsworth

Wed 24 Aug

14:00-15:30C41 Advances in statistical issues inepidemiology 2

Self-controlled case series with multipleevent types

YonasGhebremichael-Weldeselassie

Risk Prediction Using Nested Case-Control Data

Agus Salim

The resurrection of time as acontinuous conceptin biostatistics,demography and epidemiology

BendixCarstensen

Determining the likely place of HIVacquisition for migrants in Europecombining subject-specific informationon migration history, risk factors andbiomarkers data

NikosPantazis

Limitations of the incidence densityratio for the analysis of adverse events

Ralf Bender

Wed 24 Aug

14:00-15:30C42 Causal inference and mediationanalysis 2

Modeling time-varying exposure forinverse probability of treatmentweights: extending the R ipw package

NathalieGRAFFEO

Using multiple imputation and selectingthe best multivariable fractionalpolynomial (MFP) model to balancepredictors of mortality betweentreatment groups

SuzanneIngle

Multiple imputation methods forestimating causal treatment effects intrials with non-compliance

KarlaDiazOrdaz

Causal inference in a multi-state modelfor work, unemployment, highereducation, sickness absence anddisability.

Rune Hoff

An extension of missingness graph forrepeated measurements of multi-dimensional markers

VahéAsvatourian



Wed 24 Aug


Stratifying population life tables bysocioeconomic status and comorbidityby using a control population

HannahBower

A probabilistic record linkage model forsurvival data

Michel Hof

The use of registry data to extrapolateresults from randomised clinical trials(RCTs): an example in metastaticmelanoma

ReynaldoMartina

Analysing epidemiological data in thepresence of informative censoring:using external data to estimate aparticipant-specific change in thehazard at time of censoring

EdmundJones

Dynamic prediction of survival usinglandmarking in large longitudinalobservational patient databases:challenges and solutions

Ruth Keogh

16:00-17:30C44 Early phase clinical trials 2

Comparison of phase II designs usingtime-to-event endpoint with a reducedfollow-up.

Lisa Belin

A Bayesian weighted quasi-likelihooddesign for phase I/II clinical trial withrepeated dose administration inpreterm newborns.

MorenoUrsino

Decision-theoretic design for a series ofphase II trials with correlatedtreatment effects

Siew WanHee

Improving phase II oncology trial usingbest observed RECIST response as anendpoint by modelling continuoustumour measurements

CHIEN-JULIN

Decision Making in Basket Trials: AHierarchical Weights Approach

ThomasBengtsson

Wed 24 Aug

16:00-17:30C45 Analysis of observational studies 4Interclass correlation coefficients forexplaining inter-hospital variations in lengthof stay

Lynne Moore

Prognosis research and the importance ofmeasuring predictors at the intendedmoment of use: an illustrative example fromgeneral practice

RebeccaWhittle

A comparison of the hybrid CART-LOGITmodel and tree based random forest modelfor prognostication of patients withtraumatic brain injury

Vineet KumarKamal

An application of the latent class modellingto predict risk of mortality among cases ofacute poisoning

KashifShafique

GROUP SEQUENTIAL METHODS APPLIED INPSYCHOLOGICAL RESEARCH ON ASUBJECTIVE WELL-BEING SURVEY INAUSTRIA

KlemensWeigl

16:00-17:30C46 Advances in statistical issues inepidemiology 3Multilevel Modeling of Binary Outcome inThree Level Complex Health Survey Data

Shafquat Rozi

Multilevel regression and poststratificationfor addressing participation bias in healthsurvey data

John Carlin

Scaled logistic regression Erik Van Zwet

Which Performance Measures to use inExternal Validation of a MultivariablePrognostic or Diagnostic Prediction Model?

HarbajanChadha-Boreham

Breast cancer tumour growth models understable disease population assumptions

GabrielIsheden

16:00-17:30C47 Longitudinal data analysis 2Dynamic Allocation schemes using credibleintervals and multivariate generalised mixedmodels.

David Hughes

A Comparison of Estimation Approaches forGeneralized Additive Mixed Models withBinary Outcomes

MuhammadMullah

Investigating momentary level change inintensive longitudinal data

Lesley-AnneCarter

Early detection of patients with high risk ofdeveloping end-stage renal disease inprimary care

Ozgur Asar

Accounting for uncertainty in the timing ofseroconversion in combined models for pre-and post-treatment CD4 counts in HIV-patients

Oliver Stirrup

Wed 24 Aug

16:00-17:30C48 Diagnostic tests

On Evaluation of Reliability,Repeatability, and Reproducibility inLaboratory Testing

SamirSALAH

Meta-analysis of test accuracy studiesusing imputation for partial reporting ofmultiple thresholds

J. Ensor

Empirical assessment of univariate andbivariate meta-analyses for comparingthe accuracy of diagnostic tests

YemisiTakwoingi

The cost of not having a perfectreference

Ana Subtil

Does ignoring clustering in multicenterdata influence the performance ofprediction models? A simulation study

LaureWynants

16:00-17:30C49 Other 4

Combining imaging and visual fieldoutcomes for clinical trials in glaucoma:is estimation of treatment effectsimproved?

KatyMorgan

Endogenous estimation of wait listdynamics

DanielaBond-Smith

Design and analysis of the Ebola_Txtrial evaluating convalescent plasma forEbola virus disease in Guinea

JozefienBuyze

Dynamics in efficacy outcomes ofcontrol group regimens in clinical trialsover time: An analysis of HER2+ breastcancer trials with Herceptin pluschemotherapy

EvelineNüesch

Safety analysis for personalised, flexibetreatment regimens

CorneliaDunger-Baldauf



Thu 25 Aug

09:30-15:00 MS1: Statistical methods inrare diseases and smallpopulations

Designs for Clinical Trials inRare Cancers

09.30-09.45 Overview on IRCI and statisticalissues in design of clinical trials inrare cancers

Cindy Billingham,Birmingham, UK

09.45-10.15 How do you design trials insmaller populations? A framework

Tim Morris, London,UK

10.15-10.45 Approximate analysis ofcovariance in trials in rarediseases, in particular rare cancers

Stephen Senn,Luxembourg

10:45-11:15 Refreshments11.15-11.45 The BALLAD study Jim Paul, Glasgow,

UK11.45-12.30 Panel Discussion12:20-13:30 Lunch

Statistical methods forextrapolation

13.30-14.00 Using historical data to informextrapolation decisions in children

Lisa Hampson,Lancaster, UK

14.00-14.30 An Extrapolation Framework toSpecify Requirements for DrugDevelopment in Children

Gerald Hlavin,Vienna, Austria

14.30-15.00 A unified approach forextrapolation and bridging adultinformation in early phasepaediatric dose-finding studies

Sarah Zohar, Paris,France

09:00-15:30 MS2: Strengthening analyticalthinking for observationalstudies (STRATOS)

09.00-09.25 Steps to derive guidance forvariable selection and functionselection

Willi Sauerbrei,Frieburg, Germany

09.25-09.50 Initial data analysis – a temporaryview

Saskia LeCessie,Leiden, Netherlands

09.50-10.15 Evaluating Diagnostic Tests andPrediction Models: a review ofexisting guidance

Gary Collins,Oxford, UK

10.15-10.40 On some practical issues in theanalysis of survival data

Maja Pohar-Perme,Ljubljana, Slovenia

10:40-11:00 Refreshments11.00-11.25 Study design: title tba tba

11.25-11.50 Measurement error in nutritionalepidemiology: challenges, currentpractice, and the scope forimprovement’

Ruth Keogh,London, UK

09.50-10.15 Key topics for guiding design andanalysis of high-dimensional data’

Harald Binder,Mainz, Germany

12.15-12.40 Causal questions and principledanswers: exposures, populations,and effect estimation’

Bianca De Stavola,London, UK

12.40-14.00 Lunch14.00-14.45 Discussions on the future of

STRATOS

Open session

14.45-15.30 Discussions on the future ofSTRATOS

Internal meeting forSTRATOS members

09:00-17:00 Students' Day09:00-09:15 Welcome: Nadine Binder09:15-09:45 Biostatistical Research Skills Robin Henderson

Session 1: Challenges in clinical trials09:45-10:00 Blinded and unblinded sample size re-

estimation procedures for stepped wedgecluster randomised controlled trials

Michael J Grayling

10:00-10:15 A comparison of unequal cluster sizes instepped-wedge cluster randomised trials

Caroline Kristunas

10:15-10:30 Statistical design and analysis ofproportionate intervention trials: asystematic review. Challenges inundertaking methodological systematicreviews

Jane Candlish

10:30-10:45 Discussion10:45-11:00 Refreshments

Session 2: Bayesian techniques11:00-11:15 Quantitative, qualitative or both? Gemma Clayton11:15-11:30 Adaptive Tolerance Range for Clinical

Biomarkers using Bayesian ApproachesDavood RoshanSangachin

11:30-11:45 Personalised medicine research in type 2diabetes: study findings may be dependent onhow response to a therapy is initially defined

John Dennis

11:45-12:00 Feeling stuck in research: lessons learnedfrom studying heterogeneity in measures ofclinical utility

Laure Wynants

12:00-12:15 Discussion12:15-13:15 Lunch13:15-13:45 Developing a Career in Biostatistics Katherine Lee

Session 3: Longitudinal and time-to-event data13:45-14:00 Estimating a cumulative incidence under

calendar time trendsStefan NygaardHansen

14:00-14:15 Jack-knife pseudo-observations and theiruse in regression analyses

Morten Overgaard

14:15-14:30 Association of childhood head growth withadult systolic blood pressure: findings fromthe New Delhi Birth Cohort

Shivam Pandey

14:30-14:45 The use of joint model for longitudinal andtime-to-event data: an application on kidneytransplantation

Marie-CécileFournier

14:45-15:00 Discussion15:00-15:15 Refreshments

Session 4: Programming and simulation methods15:15-15:30 Julia – a serious alternative to R for

biostatisticians?Daniela Zöller

15:30-15:45 Simulation study on the estimability ofdistribution parameters in the context ofobservations below the lower limit ofquantification (LLOQ)

Tanja Berger

15:45-16:00 Simulating high-dimensional molecular data Julia Krzykalla:16:00-16:15 Discussion16:15-16:45 The Future of Biostatistics Hans van Houwelingen

16:45-17:00 Discussion and Farewell



Poster Sessions: All poster presenters should be at their poster to answer questions during the refreshment break at the time indicated below.

# Poster Title Author Day, time

Causal inference and mediation analysis001Causal Path Framework for Factors Influencing Anemia in Pregnant Women in

IndiaMona Pathak Mon AM

002Mediation analysis combined with competing risk approach: Total and indirecteffects of smoking on the risk of total hip and knee replacement. Prospectivedata from the Nord-Trøndelag Health Study (The HUNT Study).

Milada CvancarovaSmåstuen

Mon PM

003Causal Modelling in non-inferiority and equivalence trials MartinaMcMenamin

Tue AM

Advances in statistical issues in epidemiology005Estimating case fatality risk and reproduction number for Ebola disease using

daily notification dataZheng Chen Wed PM

006Improving Prediction of Post-Neonatal Mortality Risk with Multilevel Model Bhaskar Thakur Mon PM

007Spatial Smoothing of Low Birth Weight Rate in Bangladesh using BayesianHierarchical Model

Mohammad SamsulAlam

Mon PM

008Title: Composite scores and health outcomes: Further investigation of theestimated associations

EvangeliaChristodoulou

Tue AM

009Prediction models for future clustered data without removing the randomintercept: A Bayesian approach

Haifang Ni Wed AM

010Determining the influence of missing data on estimates of ambient pollutionexposure-mortality risk.

Matthew Gittins Wed PM

011Monte-Carlo analysis of multilevel binary logit model to improve theprediction

Bhaskar Thakur Tue AM

012New approaches to estimate the Population Attributable Fraction in SurvivalAnalysis: a practical case in the EPIC Study

Catalina BonetBonet

Tue AM

Analysis of observational studies013rANCOVA - A Robust Method for Covariate Adjustment in Observational

StudiesThomas Forstner Tue AM

014Domain structures of the EORTC QLQ-HCC18 and QLQ-C30 for patients withhepatocellular carcinoma

Wei-Chu Chie Wed AM

015The effect of N-acetylcysteine on cardiac toxicity of Aluminum phosphidepoisoning

MortezaHajihosseini

Wed PM

016Prevalence of Non-Communicable Disease in General Population, East of Iran,2014- 2015: WHO 25˟25 Target

MortezaHajihosseini

Tue AM

017On the advancees about the use of parametric copulas in a observationalstudies framework

Charles Fontaine Mon PM

018Adverse effect of tobacco use on pregnancy outcome: a multi-center hospitalbased case control study in urban settings of Karachi, Pakistan

Shafquat Rozi Mon AM

019Predictors of smoking uptake in male adolescents attending public andprivate schools in Karachi, Pakistan: Multilevel modeling of survey data

Shafquat Rozi Wed AM

020Investigating the Impact of Missing Confounders in Propensity Score Analysesof Treatment Effects

Eleni Frangou Wed PM

021Complex measures of health inequalities for family planning methods amongwomen: Demographic and health survey data

Kashif Shafique Mon AM

022Evaluation of medication persistency using Korean National Health InsuranceService-Cohort Sample Database

Ye-Jee Kim Mon PM

023Restricted cubic splines for cyclic data Lara Lusa Tue AM


024The impact of rare outcomes on statistical power and correctness of theinterpretation of results

Rianne van denBroeke

Wed AM

025Performance of the marginal structural Cox model for estimating individualeffects of treatments given in combination in observational study: asimulation study

Clovis LusivikaNzinga

Wed PM

026Truncated Logistic Regression Method in Matched Case-Control Studies Muzaffer Bilgin Mon PM

Diagnostic tests027A comparison of one-sided testing procedures in evaluating the performance

of the diagnostic testKanae Takahashi Mon AM

028A clinical prediction score for appendicitis ChumponWilasrusmee

Tue AM

029COMPARISON OF DIAGNOSTIC PERFORMANCE OF REPEATEDMEASUREMENTS AND BASELINE MEASUREMENT OF TROPONIN-I INPREDICTING DEATH IN AN EMERGENCY SETTING

Naime Meric Konar Tue AM

030Balancing Sample Distributions for Cut Point Determination of Biomarkers inSurvival Data

JungBok Lee Wed AM

031The determination of the optimal cutoff value for two continuous variable:ROC Analysis or Logistic Regression Analysis?

Serdal Kenan KÖSE Wed AM

Pharmacoepidemiology and drug safety032A novel method for detecting adverse drug interactions in spontaneous

reporting systemsMasahiko Gosho Tue AM

033Comparison of Probit, Logit and Spearman-Kärber Methods in QuantalResponse Assays via Simulation

Merve Sevinc Wed PM

034A meta-analysis of the safety of bevacizumab therapy in patients with solidtumors

Almut Mecke Mon AM

Big data in healthcare035A practical approach to using propensity score matching when analysing a

large non-randomised dataset: The long-term survival for patientsundergoing volatile versus IV anaesthesia for cancer surgery

Kabir Mohammed Mon PM

036The Effect of Low-dose Radiation Exposure on Cataract from nationwidecohort data in Korea (2002-2013)

Taemi Youk Wed AM

037Monitoring the impact of the Preterm Birth Prevention Program: evaluation ofclinical effectiveness using historical controls

Dorota Doherty Tue AM

038Penalized Canonical Corelation Analysis combining genomic, proteomic,laboratory and clinical phenotypic data

Wouter Ouwerkerk Mon AM

Longitudinal data analysis039Trajectories of Future Spherical Equivalent Refraction in School-aged Children

using the Longitudinal Data from the Guangzhou Twins Eye StudyJing Xie Wed PM

040Joint Modeling of Bottle Use, Daily Milk Intake from Bottles, and Daily EnergyIntake in Toddlers

Yungtai Lo Mon AM

041Use of z-scores to concurrently model fetal measurements alongsidechildhood lung function (FEV1) in relation to asthma outcomes

Shona Fielding Mon PM

042Measuring outcomes associated with prescription drugs using routinelyrecorded primary care data

Lauren A. Barnett Tue AM

043The Effect of Co-morbidity on The Modelling of Migraine Prognosis Didem DericiYildirim

Wed AM




044Risk of mortality associated with changing electrolyte values in malnourishedAfrican HIV-infected adults given vitamins and minerals in lipid-nutritionalsupplements (LNS-VM): a randomised controlled trial

Andrea Rehman Wed PM

045Adaptive Tolerance Range for Clinical Biomarkers using Bayesian Approaches Davood RoshanSangachin

Mon AM

046Evolution Profiles in Body Mass Index for Spinocerebellar Ataxia Type 1, 2, 3and 6: influence of the size of the subgroup

Diallo Alhassane Mon PM

047A multi-state approach instead of "ventilator-free days" composite outcome inintensive care studies.

Denis Frasca Tue AM

048A joint model approach to discriminant analysis with two continuouslongitudinal biomarkers and discrete response

Malihe Nasiri Wed AM

049BAYESIAN ANALYSIS OF RECEIVER OPERATING CHARACTERISTIC CURVESFOR ORDINAL SCALED DATA UNDER STOCHASTIC ORDERING

Eun Jin Jang Wed PM

Missing data050Imputation of Missing Data for a Continuous Variable with anOrdinal form of

Risk Function: When to Apply the Transformation?Saiedeh Haji-Maghsoudi

Wed PM

051A Bayesian Nonignorable Nonresponse Model for Three-way Tables fromSmall Areas

Namkyo Woo Mon AM

052Parameter estimations for various distributed data with observations below alower limit of quantification

Tanja Berger Mon PM

053Dealing with missing data in an Individual Participant Data Meta-Analysis:one-stage versus two-stage methods

Thomas Debray Tue AM

054Methods to handle survival bias in the analysis of hospital length of stay Lynne Moore Mon PM

055Variable Selection with multiply imputated data when fitting a Coxproportional hazards model: a simulation study

Olga Kalinina Tue AM

056Tipping Point Analyses in Studies with Survival Outcome Yuliya Lokhnygina Wed AM

Survival data analysis057An application of landmarking in survival analysis: Mortality risk in a primary

care COPD populationDavid Culliford Tue AM

058Estimating sample size in the presence of competing risks - cause-specifichazard or cumulative incidence approach?

Bee-Choo Tai Wed AM

059Survival analysis adjusting for centre in a multicentre randomised trial - theeffect of a large centre with many events, and an alternative method ofadjustment using propensity scoring.

Catriona Keerie Wed PM

060How serious is bias in effect estimation in randomised trials with survival datagiven risk heterogeneity and informative censoring?

RoseanneMcNamee

Tue AM

061Survival benefit in liver transplantation by categories of severity scores usingthe Model For End-Stage Liver Disease (MELD) and the Donor Risk Index(DRI).

Audrey Winter Mon PM

062Robustness of Estimation Methods in a Survival Cure Model with MismeasuredCovariates

Aurélie Bertrand Tue AM

063SURVIVAL PATTERN, TREATMENT OUTCOMES AND PROGNOSTICDIFFERENTIALS AMONG DIRECTLY OBSERVED TREATMENT STRATEGYTUBERCULOSIS PATIENTS IN A TERTIARY FACILITY, SOUTH-WESTERNNIGERIA.

Oluwatosin AkinsolaWed AM

064Methods for imputation of time to graft-versus-host-disease followingtransplant of allogeneic haematopoietic stem cells from umbilical cord blood

Elinor Curnow Wed PM

065Visualizing survival data using Bayesian imputation Shirin Moghaddam Mon AM

066R²-type curve to evaluate dynamic predictions Marie-CécileFournier

Mon PM


067Reduced sample size requirements for time to event studies Rory Wolfe Tue AM

068A high dimensional mixture model for time-to-event data Bussy Simon Wed AM

069Accelerated Failure Time Model with one covariate subject to random rightcensoring

Hervé MartinezAZOBOU ANANTIA

Wed PM

071Evaluating time dependent factors on peritoneal dialysis survival using timedependent coefficient models

MaryamSeyedTabib

Mon PM

072Comparison of survival curves; a simulation study Emre Demir Tue AM

073Comparison of approaches for extrapolating survival curves for clinical trialsdata using flexible parametric modelling

Lynsey Chudleigh Wed AM

074Exploring and understanding survival data using Cox proportional hazardsand Aalen's additive model

François Lefebvre Wed PM

075Quantifying the association between progression-free and overall survival incancer trials

Enya Weber Mon AM

076A modified version of average hazard ratio for overall survival when longpost-progression survival is expected.

Shogo Nomura Mon PM

077Modelling neurological outcomes in patients with successful cardiopulmonaryresuscitation following cardiac arrest in the presence of incomplete data

Zdenek Valenta Tue AM

078Flexible parametric survival models for registry data: How much freedom dowe have in selecting the degrees of freedom?

ElisavetSyriopoulou

Wed AM

079Reconstructing paired individual patient level data for Progression-free andOverall Survival from summary information

Rebecca Boucher Wed PM

080Cox proportional hazards regression with tree-structured modeling in patientswith nasopharyngeal cancer

Niyet Evdönderen Mon AM

081Generalizations of the c-index for survival data Natasa Kejzar Mon PM

082Practical aspects of multistate modeling with multipletime scales Bendix Carstensen Wed AM

083Additive hazard models with a shared frailty for semi-competing risks data Jinheum Kim Tue AM

084Dynamic predictions of metastasis free survival in bladder cancer NURIA PORTA Wed PM

085Comparison of Nonparametric Randomization Based Analysis of Covarianceand Cox Proportional Hazards Models: An application on patients with chronicobstructive pulmonary disease (COPD)

Serdal Kenan Kose Mon AM

086Penalized likelihood parameter estimation for semiparametric additive hazardsmodel with interval-censored data using method of multipliers

Kasun Rathnayake Mon PM

087An evaluation of statistical methods for predicting timelines for reachingtarget number of events in clinical trials with time-to-event endpoints

Emma Clark Tue AM

088Proportion of expected life lost as a metric of the overall impact of cancer Mark Rutherford Wed PM

089Comparison of different approaches to estimate alternative survival measuresin population-based cancer research

Dimitra-KleioKipourou

Mon PM

090Using pseudo residuals to study predictive ability of scoring systems afterTransarterial Chemoembolization of Hepatocellular Carcinoma

Irene Schmidtmann Tue AM

091The Assessment of Cardiovascular Risk Factors with Respect to Cut-off Pointsby Using Joint Models

Nezhat Shakeri Wed AM

092Comparison of Cox Proportional Hazards Model and Accelerated Failure TimeModels in the Survival of Acute Liver Failure Patients

Khanal ShankarPrasad

Wed PM

093Analyzing relative survival of groups that outlive the population - the Frencholympians study

Maja Pohar Perme Mon AM

094Identification of multiple influential observations in weibull regression Mohd asrul affendiAbdullah

Mon PM

Meta analysis a medical decision making




095Network Meta-Analysis using Individual Participant Data: when do benefitsarise?

Thomas Debray Mon AM

096A network meta-analysis for comparison among vonoprazan and proton pumpinhibitors for gastroesophageal reflux disease treatment

Toshiro Tango Wed AM

097Network meta-analysis for the effect of lifestyle and metformin for delaying orpreventing type 2 diabetes by consistency and inconsistency models

Kazue Yamaoka Wed PM

098Network-meta analysis of preclinical studies - feasibility of a novel application Laura Gray Mon AM

099Effectiveness of Neoadjuvant Chemotherapy in Breast Cancer Patients: ASystematic Review and Multivariate Meta-analysis

Mona Pathak Wed PM

100Performance of screening questionnaires for obstructive sleep apnea duringpregnancy: A systematic review and meta-analysis.

Pawin Numthavaj Tue AM

101A method of multivariate t distribution for random effect multivariate meta-analysis

Wong-Shian Huang Wed AM

102Evaluation of published indirect comparisons and network meta-analyses Ralf Bender Mon PM

103The calibrated model-based concordance improved assessment ofdiscriminative ability in patient clusters of limited sample size

David van Klaveren Mon AM

104A Bayesian Hierarchical Meta-Regression Approach for Cross-Design Synthesis Pablo Emilio Verde Mon PM

105Efficacy of calcium and vitamin D supplementation on preeclampsia inpregnancy: A systematic review and network meta-analysis

SasivimolRattanasiri

Tue AM

106Role of Interleukin-10 (-1082G/A) gene polymorphism with the risk ofIschemic Stroke: A Meta-analysis

Arun Yadav Tue AM

107Statistical methods to model complex associations in individual participantdata meta-analysis

Nadine Marlin Wed PM

108The Prognostic Effect of Serum Magnesium Concentration in Patients withHeart Failure: A systematic review and meta-analysis

ThunyaratAnothaisintawee

Mon AM

109Updating and Combining Lung Cancer Prediction Models Eoin Gray Mon PM

110External Validation of Eight Lung Cancer Prediction Models Eoin Gray Tue AM

111Combining Evidences from Multiple Binary matched-Pairs Data using aBayesian approach

Toru Ogura Wed AM

112Investigating effect modification of the Incredible Years parentingintervention using individual participant data meta-analysis

Victoria Harris Wed PM

113Diagnostic accuracy of echocardiographic measurements as predictors of fluidresponsiveness in mechanically ventilated children: a systematic review andmeta-analysis

Atiporn Ingsathit Mon AM

114Estimating baseline survival from few studies: combining simple parametriccurves, elicitation, and model averaging

Sandro Gsteiger Mon PM

115Application of Bayesian Meta-Analysis in Combining Different Sources ofEvidence for Two Correlated Outcomes OSA and BMI

Shakir Hussain Tue AM

116Using network meta-analysis and decision-analytic modelling to evaluate theeffectiveness and cost-effectiveness of public health interventions to preventfalls in children under 5 years

Stephanie Hubbard Wed AM

117Evaluating the inclusion of Real World Evidence in Network Meta-Analyses toconnect disconnected networks - A Case Study in Rheumatoid Arthritis

David Jenkins Wed PM

118Multivariate network meta-analysis incorporating dose-response constraints:application to overactive bladder syndrome

Rhiannon Owen Mon AM

119Meta-analysis of time-to-event data with small treatment effects Dimitris Stogiannis Mon PM

120A comparison of methods for modeling between-study variance structure innetwork meta-analysis

Yusuke Yamaguchi Mon AM

Stratified or personalised medicine and biomarker discovery


121Risk stratification of oral cancer patients using a combined prognostic factorincluding lymph node density and biomarker

Ki-Yeol Kim Tue AM

122Incorporating data from patients with missing biomarker status intobiomarker-based trial designs

Cornelia UrsulaKunz

Wed AM

123Bayesian Adaptive Patient Enrollment Restriction to Identify a SensitiveSubpopulation using a Continuous Biomarker in a Randomized Phase 2 Trial

Shoichi Ohwada Wed PM

124HLA haplotype (phase) reconstruction based on very large, arbitrary samples Ian James Mon AM

125Design of clinical trial for immunotherapy products: impact of biomarkerstratification and delayed effect for the TIME study.

Bérangère BASTIENMon PM

126Comparing multivariate and multiple univariate tests for sets of biomarkers Måns Thulin Tue AM

127An interactive tool to assess subgroup analyses (and the resulting bias) Nicolas Ballarini Wed AM

128The clinical course of osteoporosis in HIV-infected patients: Application ofmultistate models with interval censored data

Nuria Perez-Alvarez Mon AM

129Treatment Moderator Profile: an application to randomised controlled trialdata.

Jennifer Hellier Tue AM

130Use of multivariable analysis to identify predictive biomarkers linkinggenomics data with clinical outcomes in the Triple Negative Trial (TNT)

Holly Tovey Wed AM

131Experimental design and statistical analysis to assess biomarker quantification C Mercier Mon PM

132Penalized Regression for Truncated Data: Selecting Genetic Risk Factors forPsoriatic Arthritis

Ying Wu Wed PM

133Multi-allelic risk assessment in complex disease association studies Elizabeth McKinnon Mon AM

Cluster randomised and stepped wedge trials134Latent Transition Model for Evaluation of School-Based Prevention Program Depeng Jiang Tue AM

135DISSSECT Study: Dementia Improving Staff Stress and Satisfaction -Evaluation by Cluster Trial

Muhammad SaifulIslam

Wed AM

136The MILESTONE study: Improving Transition from Child to Adult MentalHealth Care

Jane Warwick Wed PM

137Measuring the efficiency of randomization methods Dominik Grathwohl Mon AM

138A graphical method for judging the quality of a randomization method Dominik Grathwohl Mon PM

139A comparison of planned and actual cluster sizes in stepped-wedge clusterrandomised trials

Laura Gray Wed PM

140Impact of non-participation on power in cluster randomised trials: anapplication to mass drug administration interventions for trachoma control

Tansy Edwards Tue AM

141Should Complex Intervention trials be powered for a single primary outcomeonly?

Ranjit Lall Wed AM

142Robustness of cost-effectiveness analyses of data from cluster randomizedtrials against violations of the normality assumption for cost data

Md. Abu Manju Mon AM

Adaptive trial design and analysis143A simulation-based topographical framework for comparing the impact of

interim phase stopping strategies under different scenariosMansour T ASharabiani

Wed AM

144Application of adaptive design methods - A literature review. Pankaj Mistry Wed PM

145Exploration on non-inferiority test methods with non-linear margin Arsène BrunelleSANDIE

Mon AM

146An Adaptive Design in a Phase 3 Vaccine Study with Limited Follow-up Bart Michiels Wed AM

147Challenges in clinical nutritional research: How adaptive design can help? Jérôme Tanguy Mon PM

Early phase clinical trials148Comparing sampling methods for pharmacokinetic studies using the derived

parametersHelen Barnett Tue AM

149Sample Size Determination for The Assessment of Average Bioequivalence Chieh Chiang Wed PM




150Antibiotics Clinical Trials--Conduct and CDISC Implementation Challenges Denis Boisvert Mon AM

151Curtailed two-stage designs in randomized phase II clinical trials Yun Chan Chi Mon PM

152An assessment of the design, conduct and dissemination of Phase I clinicaltrials

Bethan Copsey Mon AM

153Dose individualization based on multiple gene mutations for molecularlytargeted agents

Akihiro Hirakawa Wed PM

154Model-based Dose Escalation Designs in R with crmPack Wai Yin WinnieYeung

Wed AM

155Alternatives to the 3+3 design in early phase trials on very rare diseases Maria Chiara Magri Mon AM

156Concentration-QT Analysis as a Promising Tool to Characterize the Risk of QTProlongation Early in the Clinical Development Program

Katie Patel Mon PM

Statistics in rare diseases and small populations157Determination of the prior distributions on Bayesian model parameters. Paméla EL Hajj Tue AM

158Effect of 10 different polymorphisms on preoperative volumetriccharacteristics of glioblastoma multiforme - results of a pilot study

Aenne Glass Wed AM

159Confidence intervals for standardized mortality and incidence ratios: dealingwith few counts

David Petroff Wed PM

160Influence of risk factors and the outcome of the TEOAE test on hearing lossin neonates registered in the Polish Universal Neonatal Hearing ScreeningProgram

Grazyna Greczka Mon AM

Other161All that glitters is not gold: A critical appraisal of the randomized controlled

blinded trial design (RCT)Jan ChristofSchuller

Tue AM

162Improved FWER-controlling methods for large-scale multiple testing underarbitrary dependence

Eunjung Song Wed AM

163A Comparison Study of the Methods for Combining Dependent P-Values Ozan Cinar Wed PM

164A review of outcome measures in IVF randomised controlled trials. Jack Wilkinson Mon AM

165Assessment of protocol deviations as part of central monitoring of clinicaltrials

Arne Ring Wed PM

166Minimisation with random component applied to unequal groups Sharon Tuck Mon PM

167Sample size requirements for clinical efficacy and cost-effectiveness in cancertrials using Bayesian and Frequentist approaches.

iftekhar khan Wed AM

168How to improve upon time to Statistics Report Julien Sauser Wed PM

169Universal SAS macro for generate Statisitcal Analysis Report in one click for I-IV phase Clinical Trials.

Andrey Myslivets Mon PM

170Clinical trials in organ donation and transplantation in the UK- benefits andchallenges

Laura Pankhurst Mon AM

171Maximin efficiencies for parallel, AA/BB and AB/BA designs under treatmentdependent costs and outcome variances

Math Candel Mon PM

172A paradox when comparing two correlated agreement coefficients Bernard G Francq Tue AM

173The usage of analytic hierarchy process in health studies Handan Ankaralı Wed AM

174Digital efficiency in Health Services Research: successful implementation of arapid and large scale randomised controlled trial

Victoria Cornelius Wed PM

175Cost Effectiveness Analysis of Renin-Angiotensin Aldosterone Systemblockade on Progression of ESRD in Thailand

OraluckPattanaprateep

Mon AM

176Cost-effectiveness analysis of statin used in preventing breast cancer: derivedby the potential outcome mean from a Thai cross-sectional study

UmapornUdomsubpayakul

Mon PM


177Non-inferiority trials: inconsistent guidelines, inconsistent reporting? A reviewof selected journals

Sunita Rehal Wed AM

178Validation of a French version of the ADHD-rating scale IV in children withADHD and epilepsy.

Catherine Mercier Tue AM

179Assessing the Long Term Performance of the Hospital Anxiety and DepressionScale (HADS) for Stroke Patients: Item Response Theory (IRT) Analysis

Salma Ayis Wed PM

180Statistical design and analysis of proportionate intervention trials: asystematic review.

Jane Candlish Mon AM

181Improving quality of biomedical scientific research Marta Vilaró Mon PM

182Statistics in Regulatory Affairs in www.wikipedia.org: Initiative of the ISCBStatistics in Regulatory Affairs Subcommittee (SiRA SC)

Juan V. Torres Mon PM

183The advantages of using embedded trials to investigate participant retention:an example using social pressure to affect retention in a health cohort study.

Sarah Cotterill Mon PM

184The impact of the timing of diagnostic imaging on patient outcomes Daniela Bond-Smith Wed AM

185The Reliability and Validity of Instruments Measuring Pattern Identification inKorean Medicine: A Systematic Review

Mi Mi Ko Wed PM

186RIPOSTE: Steps towards improving the design and analysis of laboratory-based biomedical studies

Dawn Teare Tue AM

187Thyroid Nodules: a highly specific combined molecular and cytologicalpredictor of malignancy

Hélène Lasolle Mon PM

188An efficient multiple testing procedure for large-scale brain connectivityanalysis

Donghwan Lee Wed AM

189Use of Image Processing Analysis in Medicine and an Application Fezan Mutlu Wed PM

190Two-sample Equivalence Test of Means in High-dimensional Data Jen-pei Liu Wed PM

191On the analysis of patient-derived high-content cancer micro tissue cultureimages

Ilmari Ahonen Mon AM

192Predicting breast cancer results: a comparison of multilayer perceptron andlogistic regression methods

BatuhanBAKIRARAR

Mon PM

193Which estimation method does best at estimating α, β and σ in Type 1 Tobit Model?

Busra Emir Mon AM

194The Use of Fractional Polynomials inBinary Logistic Regression Models forClinical Trials

Serhat Hayme Tue AM

195LASSO type Penalized Spline Regression for Binary Data Muhammad Mullah Wed AM

196On the robustness of modeling using the negative binomial distribution Júlia Singer Wed PM

197A comparison to Dropping related variables Solution and Penalized Regressionto solve the problem of Multicollinearity

Maryam Shahdoust Mon AM

198Item Analysis and Detection of Differential Item Functioning with Four-Parameter Non-Linear Regression Model

Adéla Drabinová Mon PM

199Statistical Modelling of Skewed Data in Randomised Controlled Trials UsingTransformations and Two-Part Models

James Griffin Tue AM

200Multivariate analysis of paired data: a review of methods for paired organsystems

Virginia Chiocchia Wed AM

201A statistical test for the difference between two quantiles from independentpopulations

Martina Mittlboeck Mon AM

202Robust novel tolerance intervals versus agreement intervals in a Bland-Altman plot.

Bernard G Francq Mon PM


Book Review by Matthias Herpers (DE)

Peace, Karl E Design and Analysis of Clinical Trials with Time-to-Event Endpoints CRC 2009 9781420066395

This book aims to provide a thorough overview over the design, analysisand interpretation of clinical trials in which the time to an event is thecritical endpoint. Although this book is a compilation of contributions byvarious authors, it is less heterogeneous than one might expect. However,being a compilation, this is not the standard textbook that you want to getin order to learn time-to-event analysis. Chapters 1-6 give an introductionto the theory of time-to-event analysis, how to design clinical trial with suchendpoints and applicable parametric, semi-parametric and Bayesianmethods for analysis. These chapters are, however, more a refresher forreaders who are already familiar with time-to-event analysis than a detailedintroduction and explanation of the theory of time-to-event analysis. Thatbeing said, and assuming that you do have a general knowledge of thetheory behind time-to-event analysis, this book will be tremendouslyhelpful when you have to practically apply that knowledge to a specificdataset.

All the following chapters (7-22) deal with a specific situation one mightencounter when having to plan and analyse clinical trials with time-to-eventendpoints. The structure of each chapter is similar: First the methodsneeded are introduced then the analysis of such data is discussed followedby an example, a discussion and a list of references. Sometimes the analysisis demonstrated by an example so that there is no extra section for anexample but this homogeneous structure of each chapter makes the readerforget that each chapter was written by different authors. Although someare putting more weight on the theory part while others put more one thepractical example, it still does not feel like a compilation but like a bookbeing written by a single author. Karl Peace did a good job as editor of thisbook.

In chapter 7, Generalized Log-rank Methods (GLR) are introduced as analternative to the Cox proportional hazard (CPH) model for small trials.Theory and examples are given for a scenario with no tied events times andfor tied event times. The authors also give the link between the GLR and theCPH method, showing that the GLR test is asymptotically similar to the CPHestimator but more efficient in trials with up to 100 subjects per group.

Chapter 8 deals with a problem that is often neglected in clinical trials,namely that through application of a treatment the underlying hazardfunction may change, thus violating the assumption of the CPH model thatthe underlying hazard function remains constant over time. The authors ofthis chapter show how the change point can be detected and how it can betested for. If such a change in hazard occurs the solution would be apiecewise analysis. The example demonstrates this for a hazard functionwith one change point, leading to a 2-piece model being applied. Theauthors also show how this could be generalized to a k-piece model butthey also give the downside of this approach: The theory behind suchpiecewise models is more complex and the computational resourcesneeded are quite high. Although it is clear that violation of the proportionalhazard (PH) assumption could be a problem and that piecewise modelling isan intuitive solution (with a quite complex theory behind the immediatelyunderstandable approach), I am missing a discussion of when the problemsintroduced to the CPH model through violation of the PH assumption arereally that troublesome that application of the more complex piecewisemodel is justified.

Chapter 9 to me seems a little bit out of order as it deals with graphicalmethods for the analysis of time-to-event data. Graphical methods are avital part of analyzing time-to-event data and also in assessing the fit ofyour model. And for exactly that reason, I would have expected thatchapter earlier in the book, where the theory and methods are recapped.

Chapter 10 is a practical example of problem that can occur in a specificindication, in this case, pain. The endpoint analysed in pain studies is usuallya time-weighted summary score, representing the longitudinal effect of thetreatment. However this endpoint may be confounded through rescuetreatments. It is obviously unethical to deny patients such a rescuetreatment if their pain is not sufficiently relieved by the study treatment.The authors show how to deal with the consequences of this intervention.Usually a patient with rescue medication is not eligible for analysis, but onthe other hand analyzing only those patients without rescue medication isclearly biased. So the practical question is how to impute the data afterrescue medication is given, as the data up until that point are clearly validfor analysis. Different imputation methods, such as LOCF, BOCF and WOCFare discussed and the concept of analyzing the time-to-rescue as additionalindicator for efficacy is introduced. Two real-life examples are presentedand their analysis is discussed in detail. Overall a practical and good

example of problems one can encounter in real life and one way to dealwith them.

Staying with pain trials, chapter 11 uses such studies as an example of howto deal with paired endpoints. The authors discuss various methods,parametric and non-parametric, to analyse paired endpoints. Methods arepresented for sample size estimation as well as for analysis for completeand for censored endpoints. Although two examples at the end illustratethe application of the presented methods, this practical part is rather short,making this chapter one of those that have a more theoretical focus.

Chapter 12 is written by Karl Peace himself. Using antibiotic trials asexample, he shows that some methods which compare the status of apatient at the end of a given time (in this example the micro-biotical cureand the clinical cure) but neglecting the time to cure. Peace gives a practicalexample of a trial where the time to cure was taken into account. Overall arather short chapter but a good reminder that when designing a trial oneshould ask the question “does time matter” more often.

Leaving the strict interventional setting of a clinical trial, chapter 13 dealswith the challenges one has when designing a trial investigating prevention.Prevention studies typically have a healthier population, resulting in lowerevent rates and therefore higher sample sizes. Also the endpoint is notalways unambiguous and one might have to deal with multiple events perpatient. Although time-to-first-event analysis is well established andaccepted from a regulatory perspective, analysis of multiple events can be atopic in clinical trials as well and should be considered more often, at leastas a sensitivity analysis. Using a cardiovascular phase III study as example,the authors go through the issues coming through the preventive endpointand show how they dealt with them. Especially the point of multiple eventsper patients and ways to analyse multiple events is noteworthy and in myopinion would have deserved a chapter of its own, making this chapter evenmore valuable to the reader.

Chapter 14 discusses some issues related to the design and analysis of trialswith anti-viral therapies. In contrast to the previous chapters, this chapterdeals not with specific statistical problems and methodological solution butappears more like a guideline on what to consider when designing andanalyzing an anti-viral trial. The statistical methods used for time-to-eventanalysis are straightforward: CPH modelling and Kaplan-Meier-Estimates. Toall but an inexperienced statistician, this is a chapter one might easily skipwithout missing something.

In chapter 15, the reader is presented with a problem one is more likely tohave in the pharmaceutical sector: Successful treatment resulting in cure.While that is a very desired outcome of research, it is a problem instatistical analysis when dealing with time-to-event data. If a proportion ofpatients in a study is actually cured, their hazard function is zero and the PHassumption of the CPH model is violated. Cure rate models are the solutionto this problem and the authors present these type of models withexamples from a melanoma study and a prostate cancer trial. These typesof models will have to be considered more often as treatment of canceradvances and (proportions of) patients being actually cured happens moreoften.

Staying with cancer studies, chapter 16 introduces the problem of multiple(non-fatal) competing risks. This chapter covers a lot of problems, like usingprogression free survival as endpoint, having tumour shrinkage and/orcomplete remission as an additional indicator of efficacy, which one mayface in an oncology study in only 12 pages. How to deal with such problemsis shown at the example of a leukaemia trial but given the shortness of thechapter, this can only be an introduction of the problems and giving thereader the methodological key words how to deal with them. Consequently,the discussion gives a lot of books in which one may find more detailedinformation. Overall too short but at least one might find a starting point ofwhere to look further, if faced with such problems.

(ctd…)


Book Review by Matthias Herpers (DE) (continued)

Having just complained about chapter 16 being too short, a suggestion ofhow to get more space follows immediately afterwards. Leave out chapter17 and give the resulting free pages to chapter 16. Chapter 17 is adescription of the design and analysis of a cancer prevention trial. Apartfrom the fact that issues of prevention trials have been covered in aprevious chapter of this book, this chapter is structured and written morelike a primary publication of a study in a medical journal and not like a textaddressing a specific statistical problem to a statistical audience. Overall Iwould think this chapter is misplaced in this book.

Chapter 18 highlights the problem that even the best analysis method willfail, if the underlying model selected is wrong. Taking the reader again to asituation in which the PH assumption of the CPH model is violated, theauthors present the LASSO method known for variable selection in thelinear model as a robust alternative to the Cox models partial likelihoodmethod, especially for censored data. Although the authors show insimulations, as well as in application to data from a leukaemia and a braintumour study, that the LASSO method is better, they also point out that theLASSO method has issues of its own, namely the computationally effortneeded in application, making it suitable for small data sets only and thenon-parametric nature of the method, making it lose its benefit as soon asthe PH assumption approximately holds. As mentioned earlier (chapter 8), ifan alternative is presented that has issues of its own, I am missing aguideline on how much the PH assumption must be violated in order tojustify a switch to the LASSO method.

Chapter 19 deals with a problem that is not faced in the design or analysisof a study but in using its results. The authors present two algorithms ofhow treatment decisions can be made based on study data. Although usinga cancer study and, therefore, time-to-event data as example, we aredealing here with a problem of machine learning algorithms. Neitherirrelevant nor uninteresting, I do think that it is misplaced in this book.

Chapter 20 addresses a problem we may face more often in the future,namely that Adverse Event (AE) data should be analysed beyond crudeincidence rates. AE data are time-to-event data and should be analysed

appropriately, if one wants to use the full information available. It may bedue to the multiple issues that are involved in AE data, competing risks andmultiple events being just two of them. As these have been coveredbeforehand, this chapter focuses on using covariate information to detectAE signals that may not be detected in crude incidences only. Unfortunatelythe theory was only applied to a simulation study and not used in a practicalexample. However, it is clear that AE data are currently evaluatedinsufficiently and due to the time-to-event nature of AE data, methodspresented in this book may be needed in the future, as the analysis of safetydata may become more important.

Chapters 21 and 22 seem a little bit misplaced as well, as they deal withstatistical analysis of animal experiments in determining carcinogenicity.Chapter 21 deals with general issues in such trials: Was a sufficient numberof animals exposed over a long enough duration of time so that enoughanimals had a reasonable chance to develop cancer? Did the distribution ofgroups lead to homogeneity? Which methods are applicable if the numberof tumour occurrences are low? Are false-positive and false-negative errorscontrolled adequately? Are test results consistent with (reliable) historicalfindings? Statistical methods used to produce trustworthy results in suchstudies are presented. Chapter 22 presents Bayesian methods for such trialsbut as mentioned already, both chapters are not really in place in a bookthat focuses on clinical trials.

Overall, this book provides a good overview of problems one may facewhen having to deal with time-to-event data and how these could behandled. Furthermore it gives examples of where time-to-event data arecurrently not analysed with time-to-even methods, notably AE data.Although there are some points for critique and some chapters fall behindothers in terms of quality or appropriateness, and I feel that some topicswould deserve

more space, I would recommend this book to every practitioner who has todeal with time-to-event data. The reader can easily skip chapters that arenot relevant but those chapters that are relevant will justify purchasing thisbook.

Cartoon Corner

From Enrico Chavez


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ISCB Office & Executive Committee: Contact Details

Who SCs Address Tel: Email:

Bregnerodvej 132, DK-3460 Birkerod,Denmark

+45 2682 7970 [email protected] Permanent Office:

Rita Schou Contact email for ISCB emailing list(googlegroup)

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President, News Editor,Webmaster:

David W. WarneConf

Chemin du Petit-Bel-Air 115,CH-1226 Thônex, Switzerland

+41 22 700 63 80 [email protected]

Consultant Biostatistician, Geneva, Switzerland. Over the last 20 years, my main activities in medical statistics have involved designing clinical developmentprojects, and the design, conduct, analysis and reporting of clinical trials in infertility, leading to approval by various health authorities. I am especiallyinterested in non-inferiority and equivalence studies and in the practical aspects of clinical trials such as randomization and use of Bayesian methods. In2010, I moved into a new role focussing on processes, quality and outsourcing. In 2013, I started working as a consultant for various pharmaceutical, biotechand nutrition companies. Since 2015, Academic Fellow of the Research Center for Statistics, Geneva School of Economics and Management, Université deGenève.

I joined ISCB in 1992 as Newsletter Editor and have attended all the annual meetings from 1993 and taken part in most of the Executive Committee meetingsover the last 20 years. As well as editing over 40 issues of the ISCB News, I was chair of the Communications Subcommittee from 1999-2007 and run theSociety’s emailing lists. I have been a member of the Subcommittees on Conference Organising since 2004 and Membership from 2007-12. I was the chair ofthe Local Organising Committee and co-chair of the Scientific Programme Committee of ISCB27 in Geneva in 2006. In 2007, I was honoured to be made a LifeMember of ISCB. I look forward to continue helping with the organisational aspects of the Society and its annual meetings and, as an Officer of the ExCom, Iwould like to help ISCB maintain its reputation for providing highly successful annual meetings and courses.

Vice-President,

KyungMann KimEduc

Department of Biostatistics and MedicalInformatics, University of Wisconsin Schoolof Medicine and Public Health, 600Highland Ave, K6/438 CSC, Madison, WI57392-4675, USA

+1 608 265 6380 [email protected]

Professor of Biostatistics and Statistics, University of Wisconsin-Madison. His current area of research includes sequential analysis, cluster data analysis andclinical and translation research in cancer, cardiovascular disease, obesity and gerontology. He is very active in professional services to the US NationalInstitutes of Health (NIH) and as data monitoring committee member on many NIH- and industry-sponsored clinical trials in various diseases.

He has been a member of the Society since 1998. He served as an elected member of the ISCB Executive Committee during 2006-2010 and as a member andchair of the Student Conference Award Subcommittee during 2006-2010 and a member of the Membership Subcommittee during 2007-2010. Served as ISCBTreasurer from 2011-14.

Secretary:

Vana SypsaEduc,Epid

Department of Hygiene, Epidemiology andMedical Statistics, Athens UniversityMedical School, M. Asias 75, 11527, Athens,Greece

+30 210 7462193 [email protected]

Assistant Professor of Epidemiology and Preventive Medicine, Dept. of Hygiene, Epidemiology and Medical Statistics, Athens University Medical School. Ireceived a BSc in Mathematics from the University of Athens, an MSc in Biometry form the University of Reading, UK, and obtained my PhD at the Universityof Athens. During the 18 years I have been working as a Biostatistician in the University of Athens, I have been involved in the design and analysis of severalprojects, including clinical trials and epidemiological studies. My current area of research is modelling of infectious diseases and, in general, infectiousdiseases epidemiology.

I served as an elected member of ISCB Executive Committee during 2005-2008, as chair of the Epidemiology Subcommittee during 2009-2012 and asmember of the Subcommittee for Student Conference Awards during 2005-2011.

Treasurer:

Zdenek ValentaConf,NatG

Dept. of Medical Informatics & Biostatistics,Institute of Computer Science AS CR, PodVodarenskou vezi 2, CZ-182 07 Prague,Czech Republic


Works as Senior Research Scientist at the Department of Medical Informatics & Biostatistics of the Institute of Computer Science, Czech Academy of Sciencesin Prague. His professional interests include analysing data from clinical and epidemiological studies and teaching medical statistics from pre-graduate topostgraduate level. He also serves as a member of Faculty of 1000 in the field of Research and Methodology.

He currently serves as a member of the ExCom of the ISCB and was appointed as Officer for years 2015-2016 (Treasurer). He also serves as a chair of theISCB’s sub-committee for National Groups and is a chair of the Czech National Group of the ISCB.


ISCB Office and Executive Committee: Contact Details (continued)

Who SCs Address Tel: Email:

Chris MetcalfeStCA,NatG

School of Social and Community Medicine,University of Bristol, Canynge Hall, 39Whatley Road, Bristol, BS8 2PS, UK


Chris Weir SiRA

Edinburgh Health Services Research Unit,Centre for Population Health Sciences,University of Edinburgh Medical School,Teviot Place, Edinburgh, EH8 9AG, UK


Hein PutterNatG,StCA

Department of Medical Statistics andBioinformatics, Leiden University MedicalCenter, Postzone S-5-P, PO Box 9600, 2300RC, Leiden, Netherlands


Jeremy TaylorEduc,StCA

Department of Biostatistics, University ofMichigan, 1415 Washington Heights, AnnArbor, MI, 48109, USA


Katherine LeeConf,StCa

Murdoch Children’s Research Institute,Royal Children’s Hospital, Flemington Road,Melbourne, VIC 3185, Australia


Stanislav KatinaNatG,SiRA

Institute of Mathematics and Statistics,Faculty of Science, Masaryk University,Kotlářská 267/2, 611 37 Brno, Czech Republic


Thomas JakiEduc,StCA

Department of Mathematics and Statistics,Lancaster University, Lancaster LA1 4YF, UK


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ISCB Subcommittees: Contact Details

Please contact the chairs/secretaries of these subcommittees for further information.

Title & Email Terms of Reference Members Email addresses

Chair:

1. David W. Warne (CH) [email protected]

Secretary:

2. Geir Egil Eide (NO) [email protected]

Members:

3. Jacobo de Una Alvarez (ES) [email protected]

4. Jörg Assmus (NO) [email protected]

5. Katherine Lee (AU) [email protected]

6. Koos Zwinderman (NL) [email protected]

7. Lucinda Billingham (UK) [email protected]

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11. Tomasz Burzykowski (BE) [email protected]

12. Toshiro Tango (JP) [email protected]

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Conference Organising

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1. Bring together ISCB conferenceorganisers or ISCB members who have aninterest in sharing and passing on theirknowledge and experience to help futureISCB conference organisers.2. Document processes and systems forassisting ISCB conference organisers.3. Review and update the documentswhenever necessary and promote theirusage for improving the procedures orconferences.

14. Zdenek Valenta (CZ) [email protected]

Chair:

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Secretary:

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Members:

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8. Maria Grazia Valsecchi (IT) [email protected]

9. Mike Campbell (UK) [email protected]

10. Rumana Omar (UK) [email protected]

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Education

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To support and organise one or two daycourses on contemporary methods inclinical biostatistics in locationsrepresented by the Society. Guidelines anda list of courses offered in the past areavailable.

12. Wenle Zhao (US) [email protected]

Chair:

1. Saskia Le Cessie (NL) [email protected]

Secretary:

2. Christina Bamia (GR) [email protected]

Members:

3. Adriano Decarli (IT) [email protected]

4. Agus Salim (AU) [email protected]

5. Catherine Quantin (FR) [email protected]

6. Ewout Steyerberg (NL) [email protected]

7. Harbajan Chadha-Boreham (FR) [email protected]

8. Nathalie Stoer (SE) [email protected]

9. Tim Ramsay (CA) [email protected]

10. Vana Sypsa (GR) [email protected]

Epidemiology

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1. Advise the Scientific ProgrammeCommittee of the annual ISCB meetings, ifneeded, on relevant topics in epidemiologyfor establishing invited sessions andchoosing invited speakers.

2. Establish connections withEpidemiological Societies and organisemutual sessions, courses or workshops atour conferences or elsewhere.

3. Generate awareness and discussions inthe Society of guidelines for conducting,analysing and reporting epidemiologicalstudies.

11. Willi Sauerbrei (DE) [email protected]


How to Contact the ISCB Subcommittees (continued)

Title & Email Terms of Reference Members Email addresses

Chair:

1. Zdenek Valenta (CZ) [email protected]

Secretary:

2. Anca Vitcu (RO) [email protected]

Members:

3. Arnošt Komárek (CZ) [email protected]

4. Chris Metcalfe (UK) [email protected]

5. David W. Warne (CH) [email protected]

6. Gordana Jovic (UK) [email protected]

7. Hein Putter (NL) [email protected]

8. Kinga Salapa (PL) [email protected]

9. Laszlo Tothfalusi (HU) [email protected]

10. Stanislav Katina (CZ) [email protected]

11. Tomasz Burzykowski (BE) [email protected]

National Groups

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1. To help those who are interested informing a National Group through theapproval process.2. To review the arrangements with thecurrent National Groups, specificallyregarding financial matters.3. To set rules and standards for funding ofISCB members of National Groups andothers from countries with exchangecontrol restrictions or barriers.4. The Subcommittee administers theConference Awards for Scientists for theannual ISCB meetings.

12. Zsolt Lang (HU) [email protected]

Chair:

1. Harbajan Chadha-Boreham (FR) [email protected]

Secretary:

2. Nicole Close (US) [email protected]

Members:

3. Chris Weir (UK) [email protected]

4. Christoph Gerlinger (DE) [email protected]

5. Christos Nakas (GR) [email protected]

6. Jonathan Siegel (US) [email protected]

7. Jørgen Seldrup (FR) [email protected]

8. Juan Vicente Torres-Martin (ES) [email protected]

9. Martin Schumacher (DE) [email protected]

10. Ralf Bender (DE) [email protected]

11. Stanislav Katina (CZ) [email protected]

Statistics in RegulatoryAffairs

[email protected]

The subcommittee on Regulatory Affairswill review, comment upon and seek toinfluence the development of regulatoryrequirements, guidelines and otherdocuments concerning the scientificaspects of data generation, collection,management, analysis, and reporting. Ingeneral, the subcommittee will seek outand handle all regulatory issues in thename of the Society with the approval ofthe President or in his/her absence, theVice-President.

12. Tim Friede (DE) [email protected]

Chair:

1. Nadine Binder (DE) [email protected]

Secretary:

2. Katherine Lee (AU) [email protected]

Members:

3. Carl-Fredrik Burman (SE) [email protected]

4. Chris Metcalfe (UK) [email protected]

5. Dimitris Rizopoulos (NL) [email protected]

6. Hein Putter (NL) [email protected]

7. Jeremy Taylor (US) [email protected]

8. Richard Cook (CA) [email protected]

9. Thomas Jaki (UK) [email protected]

Student ConferenceAwards

[email protected]

Student conference awards are availablefor registered postgraduate students toattend the annual conference and presenta paper. The Subcommittee shall receivesubmissions, judge them, and administerthe awards. The rules and procedures areannounced in a timely issue of theNewsletter and on the ISCB annualconference webpage.

10. Ulrich Mansmann (DE) [email protected]


ISCB Membership Information

The International Society for Clinical Biostatistics(ISCB) was founded in 1978 to stimulate research intothe principles and methodology used in the designand analysis of clinical research and to increase therelevance of statistical theory to the real world ofclinical medicine.

The ISCB organises an annual scientific meeting whichmembers and non-members are able to attend. Themain objective of the annual scientific meetings is tocreate an opportunity for the exchange ofknowledge, experience and ideas among clinicians,statisticians and members of other disciplines, suchas epidemiologists, clinical chemists and clinicalpharmacologists, working or interested in, the field ofclinical biostatistics.

The scientific meetings cover a broad spectrum ofbiostatistical interests and regularly include sessionson the design and analysis of clinical trials,epidemiology and statistical methodology, as well asfrom time to time considering more specialist issuessuch as, for example, education of biometricians andbiometrics users, pharmacokinetics, medicaldatabases and pharmaco-epidemiology.

Meetings in recent years have been held in Geneva(2006), Alexandroupolis (2007), Copenhagen (2008),Prague (2009), Montpellier (2010), Ottawa (2011),Bergen (2012), Munich (2013), Vienna (2014) andUtrecht (2015). The next meetings will be held inBirmingham (2016), Vigo (2017), Melbourne (2018)and Leuven (2019).

The Annual General Meeting of the ISCB is organisedto coincide with the scientific meeting. Membershipof the Society is drawn from around 50 countriesworldwide and the number of members is about1140.

The ISCB also organises courses to cover particularstatistical topics and are given by the foremostresearchers in the field. These are run to precede orfollow on from the annual scientific meeting, or arerun as separate events.

The composition of the Executive Committee(ExCom) for 2016 is as follows:Officers

President,News Editor, Webmaster

David W. Warne (CH)

Vice-President KyungMann Kim (US)Secretary Vana Sypsa (GR)Treasurer Zdenek Valenta (CZ)

MembersChris Metcalfe (UK)Chris Weir (UK)Hein Putter (NL)Jeremy Taylor (US)Katherine Lee (AU)Stanislav Katina (CZ)Thomas Jaki (UK)Toshiro Tango (JP)

The ISCB also has special Subcommittees dealing withparticular aspects of biostatistics.

The Society publishes a Newsletter twice ayear. The ISCB News editor is David W. Warne. Itemsfor inclusion in the Newsletter should be sent to himvia email to: [email protected]

Membership of the Society is open to all with aninterest in biostatistics. The current annual (to31 December 2016) Ordinary membership fee is €40.The Full-time Student and Retired Membership fee is€10. There are reduced fees for members (€20) andstudents (€5) from Developing Countries, as definedby the World Bank list. All who subscribe after Maywill have to pay an extra fee of €20.

Applications for membership should be sent by email to:

ISCB Permanent Office

Bregnerodvej 132,

DK-3460 Birkerod,

Denmark

Tel: +45 2682 7970

email: [email protected]

www: www.iscb.info


ISCB Membership Subscription

INTERNATIONAL SOCIETY FOR CLINICAL BIOSTATISTICS

2016 Membership SubscriptionSurname: First name:

Title (Prof/Dr/etc): Post held:

Institute/Company:

Address:

Post code and country:

Phone No.: E-mail:

Fax No.:

Member No.:

Please provide your email address in order to log on to the Members’Area of ISCB’s website; it may be used to send you the electronic ISCBNews in the future, and is needed for voting.

RegistrationJan.-May

Late registrationJun.-Dec.

ISCB membership to 31 December 2016:

SUBSCRIPTION: EUR 40 EUR 60 Regular members

(please tick one only) EUR 10 EUR 30 Student Member (applicable to undergraduate or postgraduate -Mastersor PhD- students) (students should provide a letter from their supervisoror head of department)

EUR 10 EUR 30 Retired members

EUR 20 EUR 40 DC members Developing Country

EUR 5 EUR 25 DC student members Developing Country

Have you previously been a member of ISCB? Yes No

New members: Please send this Membership Subscription form to [email protected] details will be uploaded to the Members’ Area of ISCB’s website,

and you will be notified when you can follow the procedure below.Current members: Please log on to the Members’ Area with your e-mail address.

PAYMENT IS MADE BY: On-line

Go to http://www.iscb.info/Members-Area.html

Apply for your password by clicking on “forgotten password”

Type your email address and click on “Send password” You receive your password by email

Log on to the Members’ Area using your e-mail address and your password.

Click Renew membership on the left-hand bar –accept conditions – accept order – select payment method – Maestro / Master Card / Visa / Visa Electron / JCB - and completepayment. You will receive an email from us confirming that you have renewed your membership once your payment is completed.

Your address details and membership category are already entered into the system. In the Members’ Area you can edit your ProfileSettings, except your e-mail address. Please contact [email protected] if you wish to change your e-mail address.

Please note that ISCB’s online payment facility is a secured system; your credit card information cannot be accessed or used for any otherpurpose.

PS: Danish VISA/Dankort cards are not supported.If you wish to pay your membership fee by bank transfer we ask you kindly to contact the Permanent Office for ISCB’s bank accountdetails ([email protected]).

Please return this form either by e-mail to: [email protected]

or by post to: ISCB Permanent OfficeBregnerodvej 132DK-3460 BirkerodDenmark

Tel: +45 2682 7970


ISCB Calendar

ISCB is affiliated to ISI. For the latest conference information, see:

http://www.isi-web.org/index.php/activities/calendar

7-10Aug

ODRS 2016 You are warmly invited to Ordered Data and their Applicationsin Reliability and Survival Analysis: An International Conference in Honourof N. Balakrishnan for his 60th Birthday held at McMaster University inHamilton, Ontario, Canada. In addition there will be a student workshopgiven by Udo Kamps (RWTH Aachen, Germany) and Barry Arnold(University of California at Riverside, USA). Location: Hamilton, Ontario,Canada Email: [email protected] Website:http://odrs.math.mcmaster.ca

8-12Aug

26th Colombian Symposium on Statistics This event is organized by theNational University of Colombia gathering local and international expertsin the main research areas of Statistics. Location: Hotel Malibú Sincelejo,Sucre - Colombia Website: http://simposioestadistica.unal.edu.co/ E-mail:[email protected]

9-11Aug

The 3rd International Statistical Conference 2016 (ISM-III) TheInternational Statistical Conference has been organised since 2012, whichwas intended to build and encourage the cooperation amongst itsmembers. This conference has been an icon to ISM as biennial eventjointly organised with local universities in Malaysia. Location: Universityof Malaya, Kuala Lumpur, Malaysia Phone: +603-79674323 Fax: +603-79674143 E-mail: [email protected] Website:http://www.ism3.um.edu.my/

24-28Aug

13th Iranian Statistical Conference The conference will be organized byIranian Statistical Society, Scheduled every two years, the conference is amajor Iranian event for statistics and probability, covering all theirbranches, including theoretical, methodological, applied andcomputational statistics and probability, and stochastic processes.Location: Shahid Bahonar University of Kerman Contact: Mohsen MadadiE-mail: [email protected] Website: http://isc13.uk.ac.ir/

5-7Sep

MBC2 3rd International Workshop on Model-Based Clustering andClassification The workshop aims at providing a focus on the state-of-the-art research in the field of model-based clustering and classification aswell as a forum of scientific discussions and comparisons among youngand senior researchers. Topics concern methodological, applied andcomputational issues in model-based clustering and classification. Theworkshop will take place in Catania (Italy) on Sep 5-7, 2016 with thesupport of the Italian Statistical Society and the Classification and DataAnalysis Group (CLADAG). Confirmed Main Lecturers: Marco Alfò (Roma,Italy), Christophe Biernacki (Lille, France), Christian Hennig (London, UK),David Hunter (PennState, USA), Richard Samworth (Cambridge, UK).Location: Collegio d’Aragona, Catania, Italy Contact: [email protected]: http://mbc2.unict.it/

5–8Sep

RSS 2016 International Conference Now in its 24th year, the conferencehas gained prestige for its focus on current statistical issues, how it fostersthe exchange of ideas and information and the quality of its speakers.Plenary speakers in 2016 will include Christl Donnelly (Imperial CollegeLondon), Anne Glover (former Chief Scientific Adviser, EuropeanCommission) and Xiao-Li Meng (Harvard University). This annualconference regularly attracts over 450 participants from all over theworld, ranging from senior academic statisticians through to newgraduates and postgraduate students, with strong representation fromthe public sector as well as statisticians and data scientists working inindustry or as independent consultants. There is also a growing group ofpeople who have an interest in statistics but who don’t work in the field.Location: University of Manchester, UK; Manchester is the 2016 EuropeanCity of Science. Website: www.rss.org.uk/conference2016 Contact:[email protected]

14–16Sep

Austrian Statistics Days 2016 Österreichische Statistiktage 2016 The mainthemes are: - Forecasting, - Market research, - Migration- and integrationstatistics, - Trends regarding the assessment of quality of life, -Visualisation. The list of keynote speaker contains (by now): Prof. HeinzFassmann (University of Vienna) und Dr. Holger Kolb (Expert Council ofGerman Foundations on Integration and Migration) on the topic ofmigration, Prof. Natalia and Gennady Andrienko (Fraunhofer Institute forIntelligent Analysis and Information Systems) on the topic ofVisualisations of time series, Prof. David Harvey (University ofNottingham) on the topic of forecasting in the area of financial bubbles,and Prof. Filomena Maggino (University of Florence) on the structure ofindicators about quality of life. Location: MODUL University Vienna,Austria E-Mail: [email protected] Website: www.osg.or.at

20–22Oct

2016 Women in Statistics and Data Science Conference The AmericanStatistical Association invites you to join the 2016 Women in Statistics andData Science Conference - the only one for the field tailored specificallyfor women! WSDS will gather academic, industry, and governmentprofessionals and students working in statistics, biostatistics, and datascience. Location: Charlotte, North Carolina, USA E-mail:[email protected] Website: www.amstat.org/meetings/wsds/2016

15-17Dec

Conference on Experimental Designs and Analysis (CEDA) 2016Experimentation is one of the most common activities in scientificresearches and industrial processes. An experiment is cost-efficient onlywhen it is carefully designed and its results are correctly analyzed. TheCEDA 2016 will highlight the most recent advances in the design andanalysis of experiments and demonstrate their applicability topractitioners in scientific and industrial communities. In addition, itprovides an excellent platform to share research ideas among seniormentors, junior researchers and Ph.D. students/graduates. This is thesecond CEDA and the first CEDA was held in Taiwan in 2014. Location:Taipei, Taiwan Website: http://www3.stat.sinica.edu.tw/ceda2016Contact Name: Frederick Kin Hing Phoa E-mail:[email protected]

19-22Dec

10th ICSA International Conference The ICSA International Conference isheld every three years in one of the cities in Asia. The theme of thisconference is Global Growth of Modern Statistics in the 21st Century.James O. Berger of Duke University, Tony Cai of University ofPennsylvania, Kai-Tai Fang of Beijing Normal University – Hong KongBaptist University United International College (UIC), Zhi-Ming Ma of theAcademy of Math and Systems Science, CAS, Marc A. Suchard of the UCLAFielding School of Public Health and David Geffen School of Medicine atUCLA, Lee-Jen Wei of Harvard University, and C. F. Jeff Wu of GeorgiaInstitute of Technology will deliver keynote presentations. Location:Shanghai Jiao Tong University, Shanghai, China Website:http://www.math.sjtu.edu.cn/conference/2016icsa/content.aspx?info_lb=22&flag=1 E-mail: [email protected]

2017:2–7Jul

IWSM 2017 With Short Course by Prof. Tom Snijders on Social NetworkModelling. This is the 32nd International Workshop on StatisticalModelling. The IWSM is one of the major activities of the StatisticalModelling Society, founded with the purpose of promoting andencouraging statistical modelling in its widest sense, involving bothacademic and professional statisticians and data analysts. The spirit of theworkshop has always been to focus on problems motivated by real lifedata and on solutions that make novel contributions to the subject, toencourage interaction as there are no parallel sessions, and to welcomeboth junior and senior statisticians. Location: Groningen, the NetherlandsWebsite: http://iwsm2017.webhosting.rug.nl/ Contact: MarcoGrzegorczyk, [email protected]

2017:9-13Jul

38 Annual Conference of the International Society for ClinicalBiostatistics The International Society for Clinical Biostatistics (ISCB) wasfounded in 1978 to stimulate research into the principles andmethodology used in the design and analysis of clinical research and toincrease the relevance of statistical theory to the real world of clinicalmedicine (moreinfowww.iscb.info). Like previous annual conferences ofISCB the 2017 conference will provide a scientific forum for internationalexchange of theory, methods and applications of biostatistics in medicalresearch and practice among clinicians, statisticians and members ofother disciplines, such as epidemiologists, clinical chemists and clinicalpharmacologists, working or interested in the field of clinicalbiostatistics. Location: Vigo, Spain Website:http://jacobo.webs.uvigo.es/Flyer_ISCB38.pdf E-mail:http://jacobo.webs.uvigo.es

2017:16-21 Jul

International Statistical Institute, 61st

ISI World Statistics CongressIncludes meetings of the Bernoulli Society, the International Associationfor Statistical Computing, the International Association of SurveyStatisticians, the International Association for Official Statistics, theInternational Association for Statistics Education, the International Societyfor Business and Industrial Statistics, and The International EnvironmetricsSociety. Location: Marrakesh, Morocco Information: ISI PermanentOffice, P.O. Box 24070, 2490 AB The Hague, The Netherlands. E-mail: Contact Phone: +31–70–3375737 Fax: +31–70–3860025Website: www.isi2017.org/

2018:Aug 26-30

ISCB39. Melbourne, Australia

2019:Jul 14-18

ISCB40. Leuven, Belgium

2020+: ISCB41, 42, 43… ?ISCB is looking for enthusiastic local organisers of conferences from 2020onwards. If you would like to know more about what this involves,please contact any of the ISCB Officers, ExCom or SCs who can let youmore about what has to be done, when.Initial proposals for 2020 should be sent to the Officers by 01 Aug 2016at the latest.

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