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CDISC UK Network TC24th September 2015

Speakers:

Paul Houston,

(CDISC Head of European Operations)

Jenny Griffiths (Roche Products Ltd)

Will Stevens (University of Oxford)

Gavin Winpenny (Roche Products Ltd)

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Agenda

• Feedback from Face to face meeting in June General feedback from F2F meeting Future TC topic suggestions CDASH / Standards Governance + Controlled

Terminology SDTM Regulatory Submissions Presentation by Gavin Winpenny on future of ADaM

standards

• AOB

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General Feedback from F2F meeting• Face to face meeting hosted by Oracle in Reading• 60 delegates from wide range of companies• 16 survey responses • All found topics relevant• All agreed panel session good way of asking

questions to the speakers• All found breakout sessions efficient way to

discuss topics in more depth• All enjoyed the venue and found the lunch / tea

breaks acceptable

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Feedback from F2F meeting

• Future topics asked for • More on CDASH and benefits of adoption .• Include overall "End to End" review of how all of

the separate components fit together to form one solution. This would be helpful as most of the people where seemed only to have knowledge of the area of CDISC that directly affects them.

• Controlled Terminology• More ADaM presentations as usage seems to be

growing.

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Questions escalated to CDISC and network professionals

• Spreadsheet to be updated continuously and issues escalated through E3C and amalgamated with other CDSIC User groups/networks

• Will be made Available on the portal

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Feedback from F2F meeting

CDASH breakout session feedback

General points:• Challenge with governing standards - protocol not

being consistent, getting the correct people to review the eCRF and for it to be targeted review

• Discussion on Davy’s presentation re. eCRF compliance tool

• CDASH version was discussed and version 2.0 is being worked on; Feedback from CDISC: The CDASH Model & CDASH IG v2 will be reviewed by SRC prior to public review at the November 16 SRC meeting

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Feedback from F2F meeting

Controlled terminology session feedback• SDTM CT general points

it is not always backward compatible requires better versioning] Better explanation when term / value is removed

• CDASH terminology is limited to a small number of domains as shown in the list below: CM, EG, EX, SU, DA and VS, so less codelists than SDTM

• CDASH terminology in most instances is subset of SDTM terminology and more generic

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Feedback from F2F meeting

SDTM breakout session feedback• Gold members now have access to CDISC SHARE

(since 10 Sept 2015). See updated list of member benefits:

http://www.cdisc.org/membership-benefits-and-options

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Feedback from F2F meeting

SDTM breakout session feedback• More implementation examples, based on real-world

trials. IG should contain guidance for the kinds of problems faced in practice. Is there any prospect of producing a comprehensive dummy

trial exemplifying CDISC standards, based on a real trial design?

There was a CDISC/FDA pilot in 2008-2009, SDTM datasets were created and a submission package was made for four studies. The final report was never published, but some information about it is available here:

http://tinyurl.com/o5pre73

http://www.cdisc.org/eu-interchange-presentations-2010 (Session 4)

http://support.sas.com/resources/papers/proceedings09/171-2009.pdf

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Feedback from F2F meeting

SDTM breakout session feedback• Any CDISC plans for a model for event adjudication?

Adjudication is mentioned in sections 3.2.1 and 1.7 of the cardiovascular TAUG V1 (dated Oct 2014):http://www.cdisc.org/system/files/members/standard/PDF/TAUG-CV_v1.pdf

Section 1.8: it will be addressed in a future CDISC publication.

Some interchange presentations related to adjudication:http://www.slideshare.net/SimoneSuriano/disc-europe-interchange-56-may-2015-basel-ch-clinical-endpoint-adjudication-could-a-dedicated-cdisc-standard-improve-quality

http://www.cdisc.org/system/files/all/generic/application/pdf/4_session_5c_barrie_nelson_tom_guinter_2013_11_cdisc_interchange_presentation_adjudication___nelson__guinter.pdf

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Feedback from F2F meeting

Regulatory Submissions breakout session• How to select the version required for a Submission?

Certain TAs require a later version of the standard, but the FDA is not yet accepting SDTM 3.2. Suggestion is to keep a close eye on the catalog on the for industry page and interim contact CDER

• Dataset XML? Strong business case for change: 8 characters for variable name, 40 for label and an overall limit of 200 chars limitations be removed using dataset XML. The suggestion from the CDER team members at that time was

that CDER have more work to do before deciding whether to support it. Perhaps a phase 2 pilot.

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Feedback from F2F meeting

Regulatory Submissions breakout session• EcTD – would SEND ever be included in eCTD?

SEND would fit well (Mike Harwood) Contacted ICH and FDA colleagues

• For listings are the regulators going to use SDTM, ADaM? Can we remove tables?

• Do we have to send listings for EMA? These are not requested by EMA, but are required for

FDA.

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Feedback from F2F meeting

Regulatory Submissions breakout session• Do we need a standard for the audit trail? In

Europe they want access to trial data and audit information. ODM can take audit this information, this could be a potential

standard

• When to standardize data? Do you standardize data for submission at the beginning consistently or when the trial gets called for submission? As required by your business. There comes a point when it

makes sense to realize your investment by converting lots of legacy data for cross trial analysis.

• Submitting programs for ADaM data sets? Not clear

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Feedback from F2F meeting

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Feedback from F2F meeting The future of ADaM standards?

Disclaimer:

The views expressed here are a personal viewpoint and summation of the discussion at the CDISC UK User Group meeting in June 2014.

These views expressed are not representative of BDLS (my previous employer) or Roche (my current employer).

Gavin Winpenny, Manager, Statistical Programming and Analysis at Roche

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Feedback from F2F meeting The future of ADaM standards?

How far can we go in Standardizing ADaM datasets and TFLs as an industry?

1. Do we want to?

2. Safety data – what is the situation?

3. Efficacy data – what is the situation?

4. Barriers / Drivers to Success?

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Feedback from F2F meeting The Future of ADaM standards?

Standardizing ADaM datasets and TFLs as an industry - Do we want to?

General consensus -

‘Yes, it is worth doing so,

but real difficulties in doing so’.

The building blocks are in place, the uptake is there, but as yet, no common ‘this is how we do...’.

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Feedback from F2F meeting The Future of ADaM standards?

Safety Data

Standard Datasets + TFLs

Improved Quality / Reduced

Cost

Standardizing ADaM datasets and TFLs as an industry – Safety Data, what is the situation?

For Safety Data and Analysis there could/should be far more agreement on what are the standards for datasets and for TFLs.

The benefits could be:• reduced costs,• improved quality• common understanding

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Feedback from F2F meeting The Future of ADaM standards?

Efficacy Data

TA Standards – shared scientific

understanding

Unique Analysis – Exploration and Scientific

challenge

Efficacy is far more complicated, but could build on the TA standards from SDTM and ADaM.

• Core sets of TA analyses could be defined across companies.

• Unique analyses would still be required, but would have a ‘standards’ framework to reference for TA.

Standardizing ADaM datasets and TFLs as an industry – Efficacy Data, what is the situation?

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Standardizing ADaM datasets and TFLs as an industry – Barriers/Drivers to Success - Technology?

Feedback from F2F meeting The Future of ADaM standards?

Barrier to Success:

• Many companies are heavily invested in existing technology, corporate standards and reports.

Driver to Success:

• Move conversation from ‘we like our tables to look like this’ to ‘this is how we as an industry build datasets, and the summary tables that go with them look the same’.

• Differences should not be about cosmetics, but clinical information.

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Standardizing ADaM datasets and TFLs as an industry – Barriers/Drivers to Success – Political Debate?

Feedback from F2F meeting The Future of ADaM standards?

Barrier to Success:

• Getting companies to agree what is ‘standard’ and who decides is a challenge.

Driver to Success:

• Part of the purpose of organizations such as CDISC and PhUSE is to achieve agreement and consensus across the industry. This should be an area for future exploration.

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Standardizing ADaM datasets and TFLs as an industry – Barriers/Drivers to Success – Communication and Trust?

Feedback from F2F meeting The Future of ADaM standards?

Driver to Success:

• Development and usage of standards is ultimately enlightened self-interest. No company has the perfect solution - improving standards benefits individual companies and the industry as a whole.

Barrier to Success:

• Companies may see their solutions as part of the competitive advantage they have in reduction of time for analysis and getting their drug through submission.

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Standardizing ADaM datasets and TFLs as an industry – Barriers/Drivers to Success – Enforcement of standards?

Feedback from F2F meeting The Future of ADaM standards?

Driver to Success:

• Development of expert working groups along the model of SDTM TAUG;

• Buy-in of companies to work across TAs with key stakeholders;• Regulatory Requirement - need definitive statement of requirement

from regulatory agency to create the commitment.

Barrier to Success:

• ADaM is a framework of rules by which to build datasets. If it becomes more prescriptive, who is to decide?

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Feedback from F2F meeting The Future of ADaM standards?

Enterprise-level

commercial platforms

scientific knowledge-

sharing collaboration

budget constraints

Ever increasing amounts of

data

Increasing regulatory focus on

standards

Standardize ADaM + TFLs.

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Feedback from F2F meeting The Future of ADaM standards?

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AOB

• Next TC meeting will be on 24th November• Topics TBC

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