How to avoid false conclusions: FDA finalizes long-awaited guidance on multiple endpoints in clinical trials
The FDA on Thursday finalized guidance, first drafted in 2017, that will help sponsors better understand FDA’s thinking about the problems posed by multiple endpoints in the analysis and interpretation of clinical trial results, and how these problems can be better managed.
The 26-page guidance features various strategies for grouping and ordering endpoints for analysis and applying statistical methods for managing multiplicity to control the chance of making erroneous conclusions about a drug’s effects.
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