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

 

 

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Draft Guidance for Industry Guidance on Adaptive Design Clinical Trials for Drugs and Biologics [Docket No. FDA– 2010-D-0090]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Draft Guidance for Industry on Non-Inferiority Clinical Trials [Docket No. FDA–2010–D–0075]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
 

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

 

(Last edited:2017-02-28)

Luk