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Statistics in Regulatory Affairs (SiRA)

 

Terms of Reference

  1. The sub-committee 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. 
  2. In general, the subcommittee will seek out and handle all regulatory issues in the name of ISCB with the approval of the President or in his/her absence, the Vice-President.
 

Members

  1. Stanislav Katina (CZ, Chair)
  2. Nicole Close (US, Secretary)
  3. Chris Weir (UK)
  4. Christoph Gerlinger (DE)
  5. Christos Nakas (GR)
  6. Harbajan Chadha-Boreham (FR)
  7. Harald Binder (DE)
  8. Jonathan Siegel (US)
  9. Jørgen Seldrup (FR)
  10. Juan Vicente Torres Martin (ES)
  11. Ralf Bender (DE)
  12. Tim Friede (DE)
For more details about Statistics in Regulatory Affairs please contact us at this e-mail.

 

 

Wikipedia Initiative: Guidances for Statistics in Regulatory Affairs

 

Document

Author(s), Date

Abstract, ISCB37 Birmingham
ISCB SiRA, 2016-03-21
Poster, ISCB37 Birmingham
ISCB SiRA, 2016-08-19


Abstract, ISCB38 Vigo
ISCB SiRA, 2017-02-13
Poster, ISCB38 Vigo
ISCB SiRA, 2017-06-29


User Guide
ISCB SiRA, 2017-06-19


Paper
ISCB 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 https://osp.od.nih.gov/clinical-research/clinical-trials/
and https://e-protocol.od.nih.gov/#/home
and the final template http://osp.od.nih.gov/wp-content/uploads/Protocol-Template-Version-1.0-040717.docx
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)
Comments to be submitted by 2018-02-28


 

Links to Regulatory Guidance Websites

FDA

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

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064981.htm

For Medical Devices they separate Draft Guidances from Final Guidances:

Draft are located here:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm407274.htm

Final versions are located here:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081752.htm

 

EMA

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

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000043.jsp&mid=WC0b01ac05800240cb

 

(Last edited:2018-03-07)

Luk