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FDA Finalizes Adaptive Clinical Trial Design Guidance

December 11, 2019

The FDA issued a final guidance on adaptive clinical trials, reworking its subsection on Bayesian methods and clarifying the extent of pre-specification required for the rules governing adaptations.

The revised Bayesian subsection explains the agency’s recommendations on applying that approach, including simulations, predictive statistical modeling and borrowing of information from external sources.

In comments on the draft guidance, Pfizer and other drug companies noted the rising use of Bayesian designs and sought further explanation of the agency’s thought processes on that topic, including the treatment of Type 1 errors and simulations.

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