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BIO Comments on FDA Draft Guidance on Multiple Endpoints in Clinical Trials

March 14, 2017

BIO submitted comments on the Food and Drug Administration’s draft guidance, Multiple Endpoints in Clinical Trials.

The draft guidance provides important recommendations for handling major multiplicity problems in clinical trials. However, BIO says the draft guidance fails to address a few important points, including multiplicity adjustments at the interim analysis, multiplicity adjustment on safety endpoints to control the overall false discovery rate of safety signals, elucidation of the calculation methods to be used with the truncated Holm and truncated Hochberg procedures, and basic principles, such as closed test or partition principles, which many of the multiple comparison methods in the guidance are based upon. BIO makes additional recommendations to clarify the guidance.

Download Full Comments Below
BIO Letter MultipleEndpoints FDA-2016-D-4460
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