FDA Draft Guidance on Adaptive Design Clinical Trials for Drugs and Biologics
This post was written by Paul Sheives.
FDA has issued a draft guidance document to help sponsors plan and conduct adaptive design clinical studies, and to aid agency staff in the efficient FDA review of such data. The guidance addresses topics such as: (1) aspects of adaptive design trials (e.g., clinical, statistical, regulatory) calling for special consideration; (2) tips for when to approach FDA while planning and conducting adaptive design studies; (3) suggested contents in the submission to FDA for review; and (4) considerations for the evaluation of a completed adaptive design study. FDA is accepting comments on the draft guidance until June 1, 2010.
