Statistics in Regulatory Affairs (SiRA)

Members and Terms of Reference

Title & Email

Statistics in Regulatory Affairs

Terms of Reference

The Subcommittee on Regulatory Affairs will review, comment upon and seek to influence the development of regulatory requirements, guidelines and other documents by obtaining the recommendations of ISCB members (SiRA process). This primarily concerns 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. Here the approval refers to the SiRA process for gathering the recommendations of the ISCB members and not the content of those recommendations.


1. Stanislav Katina (CZ)
2. Nicole Close (US)
3. Chris Weir (UK)
4. Elaine Pascoe (AU)*
5. Erik Cobo (ES)
6. Harald Binder (DE)
7. Jonathan Siegel (US)
8. Juan Vicente Torres‑Martin (ES)
9. Nan van Geloven (NL)
10. Ralf Bender (DE)
11. Tim Friede (DE)

* President’s Representative

For more details about Statistics in Regulatory Affairs please contact us at this e-mail.

Covid-19 Guidelines 2020

Date (pdf link)

Title (article link)

Wikipedia Initiative: Guidances for Statistics in Regulatory Affairs


Author(s), Date

Abstract, ISCB37 BirminghamISCB SiRA, 2016-03-21
Poster, ISCB37 BirminghamISCB SiRA, 2016-08-19
Abstract, ISCB38 VigoISCB SiRA, 2017-02-13
Poster, ISCB38 VigoISCB SiRA, 2017-06-29
User GuideISCB SiRA, 2017-06-19
PaperISCB SiRA, 2018-03-07
Wikipedia Page 
Wikipedia List of Guidances 

Comments made on Various Guidelines

Comments on

Author(s), Date in doc

NICE: Revised Guidelines for Manufacturers and Sponsors of Technologies Making Submissions to the Institute”, First Draft, 12 October 2000

SiRA–J.Seldrup, undated

CPMP/EWP/2330/99: “Points to consider on validity and interpretation of meta-analyses, and one pivotal study”, London, 19 October 2000

SiRA–J.Seldrup, undated

CPMP/EWP/1776/99 draft: “Points to consider on missing data”, London, 25 January 2001

SiRA–J.Seldrup, undated

CPMP/EWP/908/99 draft: “Points to consider on multiplicity issues in clinical trials”, London, 26 July 2001

SiRA–J.Seldrup, undated

CPMP/EWP/2863/99 draft: “Points to consider on adjustment for baseline covariates”, London, 14 December 2001

SiRA–J.Seldrup, undated

CPMP/EWP/2158/99 draft: “Points to consider on the choice of non-inferiority margin”, London, 26 February 2004

SiRA–J.Seldrup, undated

CHMP draft reflection paper on methodological issues in confirmatory trials with flexible design and analysis plan /Doc Ref: CHM/EWP/2459/02

SiRA–J.Seldrup, undated

Guideline on Clinical Evaluation of Diagnostic Agents / Doc. Ref. CPMP/EWP/1119/98/Rev 1

ISCB‑C.Gerlinger, undated

Guideline On Missing Data In Confirmatory Clinical Trials

ISCB, 2009-10-27

Draft Guidance for Industry Guidance on Adaptive Design Clinical Trials for Drugs and Biologics [Docket No. FDA– 2010-D-0090]

ISCB‑(?), 2010-05-20

Draft Guidance for Industry on Non-Inferiority Clinical Trials [Docket No. FDA–2010–D–0075]

ISCB‑(DWWarne), 2010-05-20

Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available (EMA/759784/2010)

ISCB, 2011-03-31

Considerations on what constitutes a ‘qualified statistician’ in regulatory guidelines

Poster at ISCB2010 in Ottawa, and

Special Issue Paper, Statistics in Medicine, DOI: 10.1002/sim.4345

Christoph Gerlinger, Lutz Edler, Tim Friede, Meinhard Kieser, Christos T Nakas, Martin Schumacher, Jørgen Seldrup and Norbert Victor, 2011-09-21

AHRQ: A Framework for assessing the Strength of Methodological Recommendations for Systematic Review and Meta-analysis

?, 2012-09-10

Guideline on the Investigation of subgroups in confirmatory clinical trials (EMA/CHMP/539146/2014)

ISCB, 2014-07-10

Draft Guidance for Industry and Food and Drug
Administration Staff, Adaptive Designs for Medical Device Clinical Studies, May 2015 [Docket No. FDA-2015-D-1439]
ISCB, 2015-08-18
Draft Guidance for Industry and Food and Drug
Administration Staff, Rare Diseases: Common Issues in Drug Development, Aug 2015 [Docket No. FDA-2015-D-2818]
ISCB, 2015-10-16
Draft Clinical Trial Protocol Template from the FDA and NIH
[Comments were to be submitted by individuals on the draft template]
See also
and the final template
ISCB, 2016-03-29
Guideline on the Evaluation of anti-cancer medicinal products in man (EMA/CHMP/205/95Rev.5)ISCB, 2016-09-14
ICH guideline E17 on general principles for planning and design of multi-regional clinical trials – Step 2b (EMA/CHMP/ICH/453276/2016)ISCB, 2017-01-27
Guideline on multiplicity issues in clinical trials (EMA/CHMP/44762/2017)ISCB, 2017-06-29
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials (EMA/CHMP/ICH/436221/2017)ISCB, 2018-02-28
FDA Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry (FDA-2018-D-3710-0001)…ISCB, 2019-01-07
EMA Consultation: Draft questions and answers on Data Monitoring Committees issues (EMA/492010/2018)ISCB, 2019-01-11
EMA Consultation: ICH guideline E8 (R1) on general considerations for clinical studies – Step b (EMA/CHMP/ICH/544570/1998)ISCB, 2019-08-15
EMA consultation: Draft qualification opinion of clinically interpretable treatment effect measures based on recurrent event endpoints that allow for efficient statistical analyses (EMA/CHMP/SAWP/291384/2019)ISCB, 2019-10-09
EMA Consultation: Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials (EMA/158330/2020)ISCB, 2020-04-20

Links to Regulatory Guidance Websites


To check for updates, please use this link for all Clinical/Medical FDA Guidances:

For Medical Devices they separate Draft Guidances from Final Guidances:

Draft are located here:

Final versions are located here:


Use this link to see the status of EMA’s Scientific Guidelines: