18 May 2015

FDA Draft Guidance for Adaptive Designs for Medical Device Clinical Studies

The U.S. Food and Drug Administration (FDA) issued a draft guidance today for Adaptive Designs for Medical Device Clinical Studies.  The document provides guidance on how to plan and implement adaptive designs for clinical studies that allow for prospectively planned modifications based on accumulating study data without undermining the integrity and validity of a trial.

Read the full draft guidance here

2 comments:

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