1. Statistics in Regulatory Affairs
ISCB Sub-Committee
Statistics in Regulatory Affairs
Terms of Reference, Membership and Report
ISCB38 Vigo 2017: AGM Wed 12 Jul

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:
Harbajan Chadha-Boreham (FR)
Secretary:
Nicole Close (USA)
Members:
1. Ralf Bender (DE)
2. Tim Friede (DE)
3. Christoph Gerlinger (DE)
4. Stanislav Katina (CZ)
5. Christos Nakas (GR, CH)
6. Martin Schumacher (DE)
7. Jørgen Seldrup (FR)
8. Jonathan Siegel (USA) +
9. Juan Torres (ES, CH)
10. Chris Weir (UK)
Note:: No change in Membership since ISCB AGM.

3. SiRA Sc: Report
SiRA Sc commented on two regulatory guidelines and compilation of ISCB comments on a third guideline is in progress. ISCB comments on:
“Evaluation of anti-cancer medicinal products in man” were submitted to the EMA on 14 September 2016 by HCB.
“ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Step 2b” were submitted to the EMA on 27 January 2017 by HCB.
“Multiplicity issues in clinical trials” will be submitted to the EMA by HCB before the closing date (30 June 2017).
SiRA Sc held a conference call on 14 November 2016 using the “Free Conference Call” service:
The main discussion topic was the Wikipedia Project on “Guidelines for Statistics in Regulatory Affairs” (i.e. creating an Outline for the Wikipedia Article and resources for initiating it in Wikipedia)
It was proposed by CG to submit a manuscript to the Biometrical Journal for the Proceedings of the ISCB 2016 Conference, following on from the Wikipedia Project Poster that was presented in Birmingham.

4. SiRA Sc: Report
A manuscript about the Wikipedia Project was submitted to the Biometrical Journal in December 2016; the reviewers recommended that it was better suited to the Pharmaceutical Statistics (PSt) journal. Hence, the revised manuscript for a “Viewpoint” will be submitted to PSt in June 2017.
A Poster about the Wikipedia Project will be 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” and “Article” about SiRA guidances were drafted by the SiRA Sc and have been implemented in Wikipedia by JT (2016) and HCB (2017), respectively. They are already “accepted” within Wikipedia after their internal review process. A related “User Guide” (drafted by HCB, JT and SK) is undergoing review by the SiRA Sc members.
In order to involve the wider ISCB Membership, a full launch of the Wikipedia Project within ISCB will take place after the PSt Viewpoint paper has been published, where a free open-access has been negotiated with Wiley Publishers for six months.