alexa Comments on the draft guidance on "adaptive design clinical trials for drugs and biologics" of the U.S. Food and Drug Administration.
Pharmaceutical Sciences

Pharmaceutical Sciences

Pharmaceutical Regulatory Affairs: Open Access

Author(s): Brannath W, Burger HU, Glimm E, Stallard N, Vandemeulebroecke M, , Brannath W, Burger HU, Glimm E, Stallard N, Vandemeulebroecke M,

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Abstract The U.S. FDA has published a draft guidance on "Adaptive Design Clinical Trials for Drugs and Biologics", which gives regulatory guidance on methodological issues in exploratory and confirmatory clinical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. This article was published in J Biopharm Stat and referenced in Pharmaceutical Regulatory Affairs: Open Access

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