1. Statistics in Regulatory Affairs
ISCB Sub-Committee
Statistics in Regulatory Affairs
Terms of Reference, Membership and Report
ISCB38 Melbourne 2018: AGM Wed 29 Aug

2. SiRA Sc: Terms of Reference and Membership
Information
Terms of Reference
Members
Statistics in Regulatory Affairs googlegroups.com
The subcommittee on Regulatory Affairs will review, comment upon and seek to influence the development of regulatory requirements, guidelines and other documents concerning the scientific aspects of data generation, collection, management, analysis, and reporting. In general, the subcommittee will seek out and handle all regulatory issues in the name of the Society with the approval of the President or in his/her absence, the Vice‑President.
Chair:
Stanislav Katina (CZ)
Secretary:
Nicole Close (USA)
Members:
1. Ralf Bender (DE)
2. Harald Binder (DE)
3. Harbajan Chadha-Boreham (FR)
3. Tim Friede (DE)
4. Christoph Gerlinger (DE)
5. Stanislav Katina (CZ)
6. Christos Nakas (GR, CH)
7. Jørgen Seldrup (FR)
8. Jonathan Siegel (USA) +
9. Juan Torres (ES, CH)
10. Chris Weir (UK)
Note:: 3 changes in Membership since ISCB AGM.

3. SiRA Sc: Report
SiRA Sc commented on one regulatory guidelines and compilation of ISCB comments on EDA or FDA guidances:
“Evaluation CH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials, step 2b – Revision 1” were submitted to the EMA on 28 February 2018 by Stanislav Katina.
The question about possibility to review EMA “Draft guideline on clinical evaluation of vaccines - Revision 1” by ISCB members was circulated among SiRA SC members on 18 June The collection of votes was closed on 25 June members agreed with the circulation, 5 were against it.
The question about possibility to review EMA “Draft questions and answers on Data Monitoring Committees issues” by ISCB members was circulated among SiRA SC members on 10 August The collection of votes was closed on 15 August members agreed with the circulation.
The question about possibility to review FDA “Draft Guidance Consultation: Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry” by ISCB members was circulated among SiRA SC members on 17 August The collection of votes will be closed on 22 Aug 2018.

4. SiRA Sc: Report
The Wikipedia Project Poster was presented at the Vigo ISCB conference. A related article was submitted for the mid-year ISCB Newsletter in order to publicise the Wikipedia Project.
The initial “List” (Wiki SiRA List) and “Article” (Wiki SiRA Article) about SiRA guidances were drafted by the SiRA Sc and have been implemented in Wikipedia by Juan Torres (2016) and Harbajan Chadha-Boreham ( ), respectively, and partially also by Stanislav Katina.
A related “User Guide” was developed by Harbajan Chadha-Boreham, Juan Torres and Stanislav Katina for the Vigo 2017 presentation.
Following the rejection of SiRA Wikipedia paper by Pharmaceutical Statistics (PSt) journal in November 2017, the Subcommittee decided not to pursue publication in a journal. Instead, it was decided to post the paper on the ISCB Website.
Consequently, the Paper has been revised addressing the PSt reviewers’ comments. As the paper required references to previous Wikipedia Initiative material (Conference Abstracts, Posters and the User Guide), it was necessary to create a specific Wikipedia section on the ISCB SiRA webpage.

5. SiRA Sc: Report
Harbajan Chadha-Boreham collaborated with David Warne for developing the following section on the ISCB SiRA webpage (ISCB SiRA web).
The webpage section contains links to all the key Wikipedia Initiative material, including the related final Paper, as well as links to the SiRA Wikipedia Page (Wiki SiRA Article) and Wikipedia List for Regulatory Guidances (Wiki SiRA List).
The above-mentioned material and related weblinks were disseminated to ISCB members via (Harbajan Chadha-Boreham, 11 March 2018) in order to encourage contributions to the Wikipedia Page and List.