I N S I D E T H I S

I S S U E :

Poster Opportunities 1

Call for Content, SCT

2020 Meeting

2-4

SCP Spotlight— Paul

Meier’s Influence on

FDA Policy

5-9

Call for 2020 SCT

Award and Scholar-

ship Applications

10

Trials Methodology

Research Priority

setting Exercise

11

SCT Webinar on

Estimands and Sensi-

tivity Analysis

11

2020 SCT Program

Committee

12

SCT 2020 Education

Committee

13-

14

13trh Annual UPenn

Conference on Statis-

tical Issues

14

SCT Sponsors 15

Information About

SCT

16

N O V E M B E R 2 0 1 9 V O L U M E 3 0 , # 1 0

By Abby Shoben and Jonathan Cook on behalf of the 2020 SCT

Program Committee

The Program Committee would like to highlight some points

regarding poster presentations at the 2020 Annual Meeting.

• New to the 2020 meeting, a selection of the abstracts ac-

cepted for a poster presentation will also be allocated a slot in

a “poster showcase” session. The poster showcase will provide

a presenter for each selected poster, two minutes to give a

snapshot of their poster, and encourage attendees to visit their

poster. Unorthodox, but engaging, short presentations are

encouraged!

• Did you know SCT has poster awards? At the conference,

awards are handed out for the best poster in three categories

(statistics, project management, and information technology).

Semi finalists for these poster awards are selected based on

submitted abstracts, and final awards are decided at the

meeting based on the poster presentation. All contributed

posters are automatically considered for these awards.

• Contributed oral and poster abstracts are due December

16, 2019.

We look forward to seeing you and lots of excellent presentations in Baltimore!

Poster Opportunities at the 2020 Annual Meeting

Abby Shoben

Jonathan Cook

Call for Content

for SCT 41st Annual Meeting

May 17 - 20, 2020 - Baltimore, MD, USA

Important Deadlines

Invited Session Abstracts Submit by December 16, 2019

Contributed Paper & Education Proposals - Submit by December 16, 2019

The Society for Clinical Trials is now accepting submissions for content for its 41st An-

nual Meeting, to be held May 17-20, 2020 at the Baltimore Marriott Waterfront Hotel.

The theme for this year's meeting is "Enhancing and Enabling the Clinical Trials Eco-

system through Interdisciplinary Collaborations." Our theme reflects the variety of ex-

pertise, disciplines and stakeholders essential to the conduct and dissemination of clini-

cal trials. The expertise includes both traditional and emerging disciplines while key

stakeholders range from academia, industry, regulators, the health system, and pa-

tients. The SCT 2020 Program Committee encourages submissions that highlight the interdisciplinary and cross-

stakeholder nature of clinical trials. SCT 2020 will also feature innovative and state-of-the-art statistical and trial de-

sign sessions - an established hallmark of our annual meeting.

Some of the key topics we are particularly interested in including in the program are:

• The value of interdisciplinary teams and the distinct roles & contributions within them

• Clinical trials related to substance abuse & the medicinal use of such substances

• The role for knowledge transfer and exchange research in clinical trials

• Clinical trial conduct: recruitment and retention, and monitoring

• Patient perspectives in participating in clinical trials design and decision making

• Emerging approaches to informed consent in clinical trials

• Challenges in addressing patient heterogeneity

• Trial design and analysis: innovations in trial methods and outcomes

The role of technology in clinical trials (including artificial intelligence)

These will also be the themes for some of the educational sessions and there are several opportunities for submis-

sions including pre-conference educational workshops, in-conference tutorials, invited sessions and contributed pa-

pers and posters. Please see below for additional information for each of these submission types.

Click here

Call for Content

for SCT 41st Annual Meeting

May 17 - 20, 2020 - Baltimore, MD, USA

Important Deadlines

Invited Session Abstracts Submit by December 16, 2019

Contributed Paper & Education Proposals - Submit by December 16, 2019

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Invited Session Proposals

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An Invited Session typically brings together a set of speakers and discussants to present the latest results of im-portant and emerging issues in an area of clinical trials research.

Formats vary for invited sessions; however, all are 90 minutes in length and have a session chair. For additional invit-ed session guidance please click here.

Invited Session Proposals need to be submitted by December 16, 2019.

Your proposal should contain the following information:

• Title

• Session organizer (with affiliation and e-mail address)

• Session chair (with affiliation and e-mail address)

• Speakers (with affiliation and e-mail addresses for each)

• Proposed session type (invited talks, panel, other)

• Written description of session, including focus, content, timeliness, appeal, and relevance to the theme, as well as specific titles for each speaker's talk (if applicable)

If you have questions about part of your proposal or want some feedback prior to finalizing your submission, please consider emailing us at info@sctweb.org

Abstracts on research relating to topics of interest to the diverse membership of the Society are requested. Submit-

ted abstracts will be considered for either an oral and/or poster session.

Those selected for oral presentations will be grouped where possible with other presentations with a similar theme. Oral presentations are usually allotted 10 to 15 minutes (inclusive of time for questions) each with four to six pre-sented in a session.

Submitted abstracts will appear in the final program exactly as submitted.

Contributed abstracts should be as accurate and specific as possible. Preference will be given to abstracts that report completed investigation, analyses, designs or methodological work over those that promise to report a work in progress if accepted.

Contributed Oral and Poster Presentation Proposals need to be submitted by December 16, 2019.

Your abstract must contain, in the following order:

• Title in all capital letters with no abbreviations

• Full name of the first author (with affiliation)

• Full names of authors without degrees or titles (with affiliation)

• Text of the abstract (500-word limit)

Contributed Orals and Posters

Contributed (continued)

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Whether the abstract should be considered for a paper and a poster session (to be decided by the Program Commit-tee) or poster session only.

Individuals can also identify if their abstract should be considered for the Thomas C. Chalmers Student Scholarship or Sylvan Green Travel Award. Please review the SCT website to determine eligibility and requirements.

Notifications on acceptance for oral or poster presentation will be communicated in February 2020.

Please note: To be certain that your proposals are received and considered, please ONLY submit Contributed Pa-pers and Abstracts by clicking here

The Education Committee invites proposal submissions for consideration for the preconference educational work-shops and in-conference tutorial sessions.

Pre-conference educational workshops will be offered on Sunday, May 17th, 2020 at an additional cost to attendees. These are typically short courses on topical methods or issues related to clinical trials typically lasting around 4 hours. The focus will be on education and training and will include hands-on work and plenty of time for questions and discussion. Please include a bullet point description of how the workshop will be structured (e.g. 10-min presentation followed by 30-mins of small group work with hands-on use of software etc.). Pre-conference Workshops are offered at an additional cost to the attendees.

In-conference tutorials will be offered during the main meeting from May 18-20th, 2020. These are interactive sessions on a method or topic related to clinical trials. Tutorial sessions are not intended to be purely didactic but will have plenty of time for discussion and may include small-group work, hands-on use of tools and software, trou-bleshooting and 'ask-the expert' time. In-conference tutorial sessions typically last 90 minutes. Please include a bullet point description of how the tutorial will be structured (e.g. 10-min presentation followed by 30-mins of small group work with hands-on use of software etc.).

For all submissions, please include the following information:

• Primary contact (with affiliation and email address)

• Whether the proposal is tied to the overall theme (including a brief description)

• Category

Target Audience

Submitted proposals will be reviewed and scored by the Education Committee, and a liaison identified for each proposal to work in close collaboration with the proponents to address the comments from the Committee. Pro-posals addressing similar topics will be encouraged to merge together to form a single proposal.

The submission portal for the pre-conference workshops and in-conference tutorials will close on Decem-ber 16, 2019.

Click here

Education Workshop Proposals

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SCT Spotlight – Paul Meier’s Influence on FDA Policy

By Chris Barker

Epigraph

Paul Meier’s Influence on FDA policy

Paul Meier was interviewed (Marks, 2004) and recalled “two years ago a very distinguished statistician told me that I had a major

influence on the Food and Drug Administration's policies on RCT's. I don't know how true that was but if so, it would be some-

thing of which I am very proud”.

Paul passed in 2011 (Hevisi, 2011) and was survived by his wife, Louise, and their three daughters, Karen, Joan and Diane.

I attempted to document Paul’s statement and gathered publicly available information by internet search and identify the statis-

tician who made the comment. I contacted people who had previously worked or currently working at the FDA and others who

knew or worked with Paul.

I did not find out the name of the statistician who made the comment to Paul. By serendipity, a remarkable finding I document

here, and appears not well known among statisticians is Paul’s and other prominent statisticians help and statistical advice to

AIDS activists during the early years of the AIDS epidemic.

Publicly Available Information on Paul’s Significant FDA Contributions

Some historical records of Paul’s work on FDA are available, Paul was an advisory committee member for Tacrine, and some his-

torical records are available for that review (Kolata, 1987….Pharmaletter). Discussions with Paul’s colleagues, such as Susan El-

lenberg, assured that Paul clearly worked on projects at FDA that weren’t necessarily reported in the press.

Paul defended FDA caution and the need for informed consent.

…Dr. Paul Meier, a statistician at the University of Chicago who is a member of an F.D.A. advisory committee, said: "The view of

some is that as long as people are informed and able to give consent, they should be free to take things that we know too little

about and take their own risks. Most people cannot be informed and consent is relatively meaningless. We count upon the agen-

cy to require that drugs be evaluated with some care." (Kolata, 1991)

Paul’s influence on FDA was certainly many-fold, for example, through his advocacy of randomization, and numerous contribu-

tions to advisory and his collaborations, guidance and advice to FDA reviewers, advisory committee members and to AIDS activ-

ists, documented below.

Paul Meier

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SCT Spotlight – Paul Meier (continued)

Assistance to AIDS activists

The major finding reported here, which does not appear to be well known among statistician is contributions by Paul and other

statisticians to AIDS activists in the early days of the epidemic. A documentary film by David France of the activities of AIDS activ-

ists, including issues around the drug AZT at the FDA is presented in “How to Survive A Plague”.

A brief overview of the sources of information.

Dr. Ellenberg suggested I contact Gregg Gonsalves about his recollection of Paul. Gregg Gonsalves, currently at Yale, was a mem-

ber of AIDS Coalition to Unleash Power (ACT UP) and commented (personal email) on Paul’s remarkable, generous assistance to

the AIDS activists.

“Suffice it to say, yes, Paul was a fellow AIDS activist. He spent time with us, taught us outside of classrooms, on his own free

time, with generosity and real friendship.”

At Gregg’s suggestion I also contacted Mark Harrington at “ACT UP” for his and his colleagues’ recollections of Paul.

Some of Paul ‘s contributions at FDA to HIV drug development are documented in his service to the FDA antiviral committee and

in miscellaneous news stories (Kolata, 1987, 1990, 1993).

I did not attempt to locate the transcripts or audio/video recordings of advisory meetings where Paul was a member.

“Paul Meier was a mentor for AIDS Activist among Statisticians”

Gregg’s email to colleagues after hearing of Paul’s passing in 2011 is online; the complete text attached as an appendix

(Gonsalves 2011). Gregg also provided further insight into Paul and other statistician role in an eloquent email attached here an

appendix (email attached with permission from Gregg).

Excerpting “What statisticians like Paul, the late David Byar and late Steve Lagakos, Jim Neaton, Victor DeGruttola, Susan Ellen-

berg, Abdel Babiker, Richard Peto taught us though is that when it comes to medicines, answers are AS important as access.

Statisticians were the first scientists to welcome AIDS activists into the world of medical research”.

Closing:

A retired regulatory statistician reported a humorous anecdote to me about Paul’s remarkable ability to persuade and negotiate.

“if Paul began a sentence with “I have a concern” ...” One knew there was a serious problem”.

Appendix

Cited with Permission

----- Forwarded Message ----- From: "Gonsalves, Gregg" <redacted> To: Chris <redacted> Sent: Wednesday, August 1, 2018 3:01 AM Subject: Re: Paul Meier (statistician)- questions Hey, Chris! So, Paul was one of a set of mentors for AIDS activists among statisticians, which include Susan, Jim Neaton, Richard Peto, Victor DeGruttola, Abdel Babiker and others. I mostly knew Jim and the UMN folks. Remember all of us were self-taught—none of the AIDS activists were trained in clinical trials and most though they went to college, had majors like Russian (me), Film Studies (Mark) or were artists, writers, etc. We also were very young.

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SCT Spotlight – Paul Meier (continued)

Thus we needed to know a lot and very quickly. The statisticians were the first to help out, to realize we were thinking crea-tively about clinical trials (e.g. parallel track). Mark Harrington from Treatment Action Group and Rebecca Pringle-Smith, now a physician in NYC, would know more about Paul’s role than I would as would my friend Bob Huff, not out in California, semi-retired. I am writing to them now on Face-book to get their email addresses. Steven Epstein at Northwestern who wrote a history of that time (he’s a sociologist) called Impure Science might have more background info. Suffice it to say, yes, Paul was a fellow AIDS activist. He spent time with us, taught us outside of classrooms, on his own free time, with generosity and real friendship.

HEALTHGAP] AIDS Activism, Data and Damn Statistics: Rest in Peace Paul Meier

Gregg Gonsalves <redacted>

Fri Aug 12 08:11:03 EDT 2011

• Previous message: [HEALTHGAP] MSF in PLoS Blog: Treatment as prevention: we urgently need policy guidance

• Next message: [HEALTHGAP] Sex Differences in the Incidence of Peripheral Neuropathy Among Kenyans Initiating Antiretroviral Therapy

• Messages sorted by: [ date ] [ thread ] [ subject ] [ author ]

http://www.washingtonpost.com/local/obituaries/paul-meier-biostatistician-and-co-inventor- of-a-famous-graph-dies-at-87/2011/08/09/gIQAfHBH7I_story.html Paul Meier died last Sunday.

Most AIDS activists won't know who he is and most really won't care.

Paul "was among the most influential biostatisticians of his generation and helped bring mathematical rigor to medical research

in the years after World War II."

What did an old biostatistician have to do with the fight against AIDS? Today, most AIDS activists see the fight against AIDS as

one of getting more drugs to more people, toppling trade barriers, boosting international and domestic spending on AIDS, an

essentially political struggle played out in the public arena of international agencies, parliaments and the press. This is almost

true.

What statisticians like Paul, the late David Byar and late Steve Lagakos, Jim Neaton, Victor DeGruttola, Susan Ellenberg, Abdel

Babiker, Richard Peto taught us though is that when it comes to medicines, answers are AS important as access.

Statisticians were the first scientists to welcome AIDS activists into the world of medical research. They taught us how to look at

data, to discern the real from the apparent, to weigh the strengths and weaknesses of analyses, how statistics can help us es-

cape our own biases, how data can be manipulated with the best of intentions.

They gave us a set of tremendous tools with which to investigate and probe data on new drugs being developed by pharmaceuti-

cal companies, gave us the ability to sit on FDA panels to provide a rigorous community-based assessment of these drugs as they

came up for approval, gave us the power to go toe-to-toe with researchers in the design and analysis of clinical trials. The statis-

ticians created the"expert-patient"--a new phenomenon in the world of public health and medicine, but one that has now liter-

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SCT Spotlight – Paul Meier (continued)

ally changed the world, not just for AIDS, but for diseases like breast cancer, TB and hepatitis. In a real way, statisticians like Paul

and the others I mentioned were the

What statisticians like Paul, the late David Byar and late Steve Lagakos, Jim Neaton, Victor DeGruttola, Susan Ellenberg, Abdel

Babiker, Richard Peto taught us though is that when it comes to medicines, answers are AS important as access.

Statisticians were the first scientists to welcome AIDS activists into the world of medical research. They taught us how to look at

data, to discern the real from the apparent, to weigh the strengths and weaknesses of analyses, how statistics can help us es-

cape our own biases, how data can be manipulated with the best of intentions.

They gave us a set of tremendous tools with which to investigate and probe data on new drugs being developed by pharmaceuti-

cal companies, gave us the ability to sit on FDA panels to provide a rigorous community-based assessment of these drugs as they

came up for approval, gave us the power to go toe-to-toe with researchers in the design and analysis of clinical trials. The statis-

ticians created the

"expert-patient"--a new phenomenon in the world of public health and medicine, but one that has now literally changed the

world, not just for AIDS, but for diseases like breast cancer, TB and hepatitis. In a real way, statisticians like Paul and the others I

mentioned were the mothers and fathers of AIDS treatment activism, they home-schooled us into data-driven warriors.

We don't talk to statisticians much anymore. There are a few old school activists still around like Mark Harrington, Simon Collins,

Polly Clayden, Tracy Swan, Lei Chou, Bob Huff, Keith Alcorn, Theo Smart, and Brenda Lein, but the newer generations of activists

didn't have the great fortune and pleasure to work with Paul and the rest of the number-crunching activists (they were so much

more than biostatisticians).

Does this matter? Am I simply being nostalgic? Am I being a pedantic prig?

Without understanding how to read clinical trial and other kind of clinical data, without knowing the relative strengths of differ-

ent ways of looking at evidence, without understanding the history of clinical research--too many activists now are at the mercy

of surrendering interpretation to others, are getting told what the data means rather than seeing it for themselves and weighing

the facts in their own hands.

In this way, we become susceptible to weak claims without knowing it, see studies as window-dressing for political campaigns

rather than as data to be interrogated first before being used to set policy.

The most terrible outcome of this is that we no longer accept or recognize that some of our claims stand on shaky evidentiary

grounds or at least in the murky twilight of conflicting evidence, and like

Sister Aloysius Beauvier in John Patrick Shanley's play Doubt, we now cry: "but I have my certainty!"

With Paul Meier's passing, one of the great AIDS activists has died. We should honor his contribution to our fight, learn from

what he taught us, reclaim that history today. It will only make us better and stronger activists.

Gregg

--

Gregg Gonsalves

<address redacted> Email: <redacted> Mobile: <redacted>

II greg gonsalves

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SCT Spotlight – Paul Meier (continued)

References

Kolata (1987, October 30) Alzheimer Drug Tested Despite Study Flaws. The New York Times. Retrieved from https://

www.nytimes.com/1987/10/30/us/alzheimer-drug-tested-despite-study-flaws.html

Kolata (1990, June 21) AIDS Drug Is Promising in Study, But F.D.A. Officials Urge Caution. The New York Times. Retrieved from

https://www.nytimes.com/1990/06/21/us/aids-drug-is-promising-in-study-but-fda-officials-urge-caution.html

Kolata (March 21, 1991), F.D.A. Urges Special Access To Rejected Alzheimer Drug. The New York Times, retrieved from https://

www.nytimes.com/1991/03/23/us/fda-urges-special-access-to-rejected-alzheimer-drug.html

Kolata, march 23, 1991, Last date of the start of new anti-cancer therapy from the Survival Follow-up CRF. The New York Times,

retrieved from

https://www.nytimes.com/1991/03/23/us/fda-urges-special-access-to-rejected-alzheimer-drug.html.

Kolata (May 19, 1991), Ideas & Trends; The Philosophy of the 'New F.D.A.' Is Mostly a Matter of Packaging,

retrieved from https://www.nytimes.com/1991/05/19/weekinreview/ideas-trends-the-philosophy-of-the-new-fda-is-mostly-a-

matter-of-packaging.html

Public Square Films presents ; a France/Tomchin film ; in association with Ford Foundation/JustFilms, Impact Partners and Little

Punk ; executive producer, Joy Tomchin, Dan Cogan ; produced by Howard Gertler, David France ; written by David France, T.

Woody Richman, Tyler H. Walk ; directed by David France. How To Survive a Plague. Sausalito, CA :Ro*Co Films International,

2012. Print.

Kolata (1993, March 1993) F.D.A. Panel Urges Approval of Alzheimer's Drug. The New York Times. retrieved from

https://www.nytimes.com/1993/03/19/us/fda-panel-urges-approval-of-alzheimer-s-drug.html

Pharmaletter, https://www.thepharmaletter.com/article/tacrine-clears-approval-hurdle, accessed dec 29 2018.

Note:

Thanks to Joan Karen and Diane for permission (as of Nov 1, 201) to submit this note to the newsletter for the Clinical Trials Soci-

ety. Thanks to my colleague Sandy Zabell, for lengthy discussions about Paul and his numerous contributions. Thanks to Gregg

Gonsalves for permission to reprint his email. Mistakes are my sole responsibility.

Once again the Society for Clinical Trials is pleased to provide two excellent scholarship opportunities to be included as part of the SCT Annual Meeting (May 17-20, 2020 in Baltimore, MD) program. For more information on the SCT Annual Meeting, visit the SCT 41st Annual Meeting page.

Registration opens in January 2020.

____________________________________________________________________________________

SCT Thomas C. Chalmers Student Scholarship

Applications must be submitted by December 16, 2019.

Who is eligible? Students enrolled in a degree program of an accredited college or university, or post-doctoral fellows.

How to Apply: Visit the online submission form by clicking here, then click Contrib-uted Sessions. Submit an abstract (500 word limit) accompanied by a short manu-script (standard font (11 or 12 pt) and one-inch margin sizes, maximum text length 5 pages, not including tables, fig-ures or bibliography; maximum total length 10 pages) and a letter from the student's advisor confirming status as a full-time student.

Submission deadline: December 16, 2019. Be sure to indicate Thomas Chalmers Student Scholarship for abstract type.

NOTE: One entry per candidate.

For more information please visit: http://www.sctweb.org/chalmers.cfm

__________________________________________________________________________________________

SCT Sylvan Green Award

Applications must be submitted by December 16, 2019.

Who is Eligible? Physicians and Dentists involved in clinical trials or epidemiology projects..

How to Apply: Visit the online submission form by clicking here, then click Contributed Sessions. Submit an abstract (500 word limit) on the online abstract submission form.

Submission deadline: December 16, 2019.

Be sure to indicate that you are an MD, DDS or DDO. NOTE: one entry per candidate.

For more information please visit: http://www.sctweb.org/green.cfm ______________________________________________________________________________________________

Spread the word about this "Call for Content" with your colleagues, students and all those interested in the design and dissemination of knowledge about clinical trials.

Questions? Email us at info@sctweb.org

Call for 2020 Applications for the Thomas Chalmers Student Scholarship and Sylvan Green Awards

Important Deadline Apply online by December 16, 2019

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A Trials Methodology Research Priority Setting Exercise –

we need your help please!

In 2013, the MRC Hubs for Trials Methodology Research ran a Delphi survey in the UK to identify current priorities for trials methodology research (1). Consensus was achieved that the top three priorities for trials methodology research were ‘Research into methods to boost recruitment in trials’ (considered the highest priority), ‘Methods to minimise attrition’ and ‘Choosing appropriate outcomes to measure’.

The MRC Trials Methodology Research Partnership (TMRP) https://www.methodologyhubs.mrc.ac.uk/about/tmrp/ is now coordinating an updated priority setting exercise and expanding the stakeholder group to capture the views of a wider international audience. The aim is to establish priorities for meth-odological research in later phase trials that are non-commercially coordinated, based upon the consen-sus of these key stakeholders.

We are seeking an enthusiastic researcher, with expertise in trials methodology research and knowledge of the US non-commercial clinical trial field, to join our team and lead the exercise within the US. The team currently includes representatives from the UK, Australia, Switzerland and Ireland. If you are inter-ested please contact Professor Catrin Tudur Smith at the Department of Biostatistics, University of Liver-pool (cat1@liv.ac.uk) for further details.

1. Tudur Smith C, Hickey H, Clarke M, Blazeby J, Williamson P. The trials methodological research agenda: results from a priority setting exercise. Trials. 2014;15:32.

Don't Miss

Estimands and Sensitivity Analysis

SCT's Next Webinar of 2019

December 11, 2019

12:00 pm-1:00 pm , Eastern Time

Speaker:

Vlad Dragalin, PhD

Vice President

Scientific Fellow Quantitative Sciences

Janssen Pharmaceutical Companies

at Johnson & Johnson

Register here

SCT Members,

Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sci-ences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QS Technical Excellence and Program Strategy) AdvisoryCommittee.

He is a PhRMA representative on ICH E9(R1) Expert Working Group and on ICH E20 Informal Working Group, a member of PhRMA Clini-cal Development Workgroup, a Member of the Drug Information As-sociation, the Society for Clinical Trials, the International Society for CNS Clinical Trials and Methodology, and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharma-ceutical Research.

This webinar will discuss the Draft ICH E9 (R1) Addendum on "Estimands and Sensitivity Analysis in Clinical Trials" proposes a structured framework that includes the specification of an estimand ("treatment effect to be estimated"), method of estimation (estimator) in the presence of informative and treatment-related events that occur after randomization, and sensitivity analysis to explore the robustness of inferences from the main estimator to deviations from its underlying assumptions.

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By Abby Shoben, 2020 SCT Program Chair

I am very pleased to introduce the 2020 Program Com-

mittee. Jonathan Cook from the University of Oxford has

agreed to co-chair this year’s committee as well as take on

the role of Chair for the 2021 Program Committee. Jona-

than brings new ideas and perspective to the committee

and I’m excited to be working with him.

The members of the 2020 Program Committee include pro-

ject managers, physicians, IT professionals, and biostatisti-

cians. The diversity in subject expertise, institutions, and

Introducing the 2020 SCT Program Committee

clinical trial experience will help create and select a diverse

and interesting program for this year’s meeting in Baltimore.

Special thanks to Letitia Perdue for leading last year’s Pro-

gram Committee and the well-received program in New Orle-

ans. As is tradition, Tisha will serve on this year’s committee

in the “past chair” role.

On behalf of the Program Committee, I’m looking forward to

your submissions and can’t wait to see you all in Baltimore!

Below is a full roster for the 2020 Program Committee:

Name Specialization(s) Affiliation

Abby Shoben (Chair) Biostatistics The Ohio State University

Jonathan Cook (Co-Chair) Biostatistics University of Oxford

Letitia Perdue (Past Chair) IT/PM Wake Forest University

Kousick Biswas Biostat/IT VA CSP Coordinating Center

Dikla Blumberg Project Management The Emmes Corporation

Jonathan Chipman Biostatistics University of Utah

Andrew Cook MD University of Southampton, UK

Karen Innes Project Management University of Aberdeen

Masha Kocherginsky Biostatistics Northwestern University

Kent Koprowicz Biostatistics Axio Research

Rebecca Lewis Project Management Institute of Cancer Research (UK)

Clement Ma Biostatistics Harvard Medical School

Graeme MacLennan Biostatistics University of Aberdeen, UK

Zhibao Mi Biostatistics VA Cooperative Studies Program

John Nichols IT Wake Forest University

Sameer Parpia Biostatistics McMaster University

Charity Patterson Biostat/IT/PM University of Pittsburgh

Julie Qidwai Project Management University of Iowa

Kyle Rudser Biostat/PM University of Minnesota

Matthew Sydes Biostat/IT MRC Clinical Trials Unit at UCL

Larisa Tereshchenko MD/PM/Biostat Oregon Health and Science University

Juilana Tolles MD UCLA

Sharon Yeatts Biostatistics Medical University of South Carolina

Wenle Zhao Biostat/IT/PM Medical University of South Carolina

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Greetings from the 2020 SCT Education Committee By Yves Rosenberg and Michael Grayling

The 2020 education committee comprises of a diverse group of SCT members, with Yves

Rosenberg and Michael Grayling as chair and co-chair this year (full membership listed be-

low). The charge of the education committee is to coordinate the pre-conference work-

shops (typically 4 hours, sometimes 2 hours), in-conference tutorials (90 minutes) as well

as the webinars that occur throughout the year (4-5 per year).

The theme of the 2020 meeting is “Enhancing and Enabling the Clinical Trials Ecosystem

through Interdisciplinary Collaborations”. Suggested topics within this theme include any

topic related to the design, conduct, analysis and reporting of clinical trials. All submissions

will be required to indicate how their proposals apply to this year’s theme. We are especially

looking forward to applications related to data and study management, IT issues, as well as

those that will appeal to the broad audience of the SCTBoth the pre-conference workshops

and the in-conference tutorials are intended to be interactive/training educational sessions

on a method or topic related to trials, including small-group work, hands-on use of tools/

software, trouble-shooting and ‘ask-the-expert’ time. Submissions should include a timed

agenda with the names of the speakers/moderators leading each section of the workshop or

in-conference tutorial. Included should be clear descriptions of how the interactive part of

the workshop will be conducted and who the target audience is. Please refer to the SCT

website to see examples of successful submissions

The Education Committee invites SCT members and other clinical trial experts to submit pro-

posals for consideration for the pre-conference short courses and in-conference tutorials. All

submitted proposals will be reviewed and evaluated by the education committee, focusing on

importance, clarity and degree of interaction. Each proposal will be appointed a liaison to work in close collaboration

with the proposers to address any comments/feedback of the education committee. Proposals addressing similar top-

ics may be encouraged to merge to form a single proposal. Submission of pre-conference workshops and in-

conference tutorials will close on December 16, 2019. We look forward to your submission!

Yves Rosenberg

Michael Grayling

Name Affiliation Role

Yves D. Rosenberg NHLBI Chair

Michael Grayling University of Cambridge, UK Co-Chair

Kousick Biswas US Department of Veterans Affairs Member

Joy Black University of Michigan Member

Kevin Buhr University of Wisconsin-Madison Member

Maria Ciarleglio Yale Member

Jody Ciolino Northwestern University Member

Lynda Constable University of Aberdeen, UK Member

Justin Presseau Ottawa Hospital Research Institute Member

Julie Qidwai University of Iowa Member

Kathryn Starr University of Aberdeen, UK Member

Kathryn A. Winter NRG Oncology Member

P A G E 1 4

Webinars

The SCT has been organizing webinars since 2014. Webinars are an hour long, covering a range of cutting-edge top-

ics, with approximately 45 minutes for the presentation and 15 minutes for questions. The next webinar is scheduled

for December 11, 2019 beginning at noon eastern time. Vlad Dragalin will be speaking on Estimands and Sensitivity

Analysis. See separate announcement in this newsletter for the link to register for this webinar, which is available to

SCT members.

Registration for each webinar opens in the member’s only section approximately one month in advance. If you have

suggestions for webinar topics or speakers, please contact the education committee co-chairs. Recordings of past

webinars can also be found on the member’s only section. We encourage you to take advantage of the wonderful

educational opportunities that the Society offers at the annual meeting as well as all year round through the webinar

series! These offerings distinguish the Society for Clinical Trials as a leader in professional associations.

_____________________________________________________________________________________________

SCT Education (continued) - Webinars

SAVE THE DATE

April 29, 2020

Registration Opens January 1, 2020

Cluster Randomized Clinical Trials (CRTs): Opportunities and Challenges

13th Annual Conference on

Statistical Issues in Clinical Trials

Rubenstein Auditorium

UPenn School of Medicine

Philadelphia, PA 19104

METHODS

David Murray, PhD (NIH) Overview: Innovations in the Design and Analysis of Group- or Clus-

ter- Randomized Trials

Victor DeGruttola, ScD (Harvard) Using Network- and Individual-Level Information in Design and

Analysis of Clustered Trials

Luke J. Keele, PhD (University of Pennsylvania) Complexities Cause by Noncompliance in Cluster Randomized Trials

James P. Hughes, PhD (University of Washington) Current Issues in the Design & Analysis of Stepped Wedge Trials

APPLICATIONS

Lawrence H. Moulton, PhD (Johns Hopkins University) Randomization: Beyond the Closurization Principle

Ira Longini, PhD (University of Florida) The Ring Vaccine Trial Design for the Estimation of Vaccine Efficacy

and Effectiveness During Infectious Disease Outbreaks

Deborah J. Donnell, PhD (University of Washington) Challenges in Implementing CRTs: From Hawthorne Effect to Meas-

urement Bias

Weili He, PhD (AbbVie) Practical Considerations in Utilizing Cluster Randomized Trials in

Medical Research

PANEL DISCUSSIONS

Karla Hemming, PhD (University of Birmingham)

David Murray, PhD (National Institutes of Health)

Michael Proschan, PhD (National Institutes of Health)

Jeffrey Roberts, MD (US Food and Drug Administration)

Alisa Shields-Stephens, PhD (University of Pennsylvania)

Monica Taljaard, PhD (Ottawa Hospital Research Institute)

VOLUME 30, #6 PAGE 15

THANK YOU TO OUR CORPORATE SPONSORS!

Platinum Sponsor

Gold Sponsors

Silver Sponsors

Bronze Sponsors

Save the Dates—Upcoming SCT Annual Meetings

P A G E 1 6 V O L U M E 3 0 , # 1 0

Executive Committee

Dean Fergusson (President)

Susan Halabi (President-Elect)

Sumithra Mandrekar (Past-President)

Domenic Reda (Secretary)

Li Chen (Treasurer)

Committee Chairs

Program: Abigail Shoben

Program: Jonathan Cook (Co-Chair)

Education: Yves Rosenberg

Education: Michael Grayling (Co-Chair)

Communications: Liz Garrett-Meyer

Development: Ivan Chan

Fellows: Mithat Gönen

Membership: Jody Ciolino and Dixie Ecklund

Nominating: Lehana Thabane

Student Scholarship: Wendy Seiferheld and

Lee McDaniel

85 W. Algonquin Road

Suite 550

Arlington Heights, IL 60005

(847) 427-8010

Executive Director

Kevin Bragaw

Administrative Assistant

Angie Stark

info@sctweb.org

www.sctweb.org

@SCTorg

@sct.org

Board of Directors

James Dignam (2017-2021)

Emily V. Dressler (2018-2022)

Alexia Iasonos (2019-2023)

Roger J. Lewis (2016-2020)

Robert Lindblad (2019-2023)

Leslie Ain McClure (2016-2020)

Will Meurer (2017-2021)

Pamela Tenaerts (2018-2022)

Elizabeth Thom (2017-2021)

Ad Hoc Committees

Scott Evans (CTTI Steering Commit-

tee)

Dean Fergusson (Planning)

Leslie Ain McClure (Code of Conduct)

Newsletter Editor—Domenic Reda

Webmaster—John Hepler

Information About

41st Annual Meeting May 17-20, 2020

Baltimore, Maryland USA

42nd Annual Meeting May 16-19, 2021

Chicago, Illinois USA