Comments on the Draft Guidance on "Adaptive Design Clinical Trials for Drugs and Biologics" of the U.S. Food and Drug Administration

The U.S. FDA has published a draft guidance on "Adaptive Design Clinical Trials for Drugs and Biologics", which gives regulatory guidance on methodological issues in exploratory and confirmatory clinical trials planned with an adaptive design. This comment summarizes the discussion within...

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Bibliographic Details
Published in:Journal of biopharmaceutical statistics 2010-11, Vol.20 (6), p.1125-1131
Main Authors: Brannath, Werner, Burger, Hans Ulrich, Glimm, Ekkehard, Stallard, Nigel, Vandemeulebroecke, Marc, Wassmer, Gernot
Format: Article
Language:English
Subjects:
Adaptive design
Bias
Biological Products - therapeutic use
Clinical trials
Clinical Trials as Topic - methods
Clinical Trials as Topic - statistics & numerical data
Data Interpretation, Statistical
Design modification
Drug Approval - methods
FDA
Flexible design
Guidelines as Topic
Humans
Interim analyses
Models, Statistical
Regulatory guidance
Reproducibility of Results
Research Design
Treatment Outcome
United States
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Summary:The U.S. FDA has published a draft guidance on "Adaptive Design Clinical Trials for Drugs and Biologics", which gives regulatory guidance on methodological issues in exploratory and confirmatory clinical trials planned with an adaptive design. This comment summarizes the discussion within the joint working group "Adaptive Designs and Multiple Testing Procedures" of the Austro-Swiss and German regions of the International Biometric Society held at the 90-day public comment period in spring 2010.
ISSN:1054-3406
1520-5711
DOI:10.1080/10543406.2010.514453