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Modifying Clinical Studies Midstream Can Be Done, With Caution, FDA Says

Adaptive device clinical trials, where study is designed in anticipation of midstream changes, are the focus on a new FDA draft guidance. Adaptive trials can reduce the duration and cost of a study without undermining its integrity, but the practice should be applied with caution, FDA says.

CDRH says its draft guidance on adaptive designs for clinical studies could help to help device manufacturers cut the cost of clinical trials.

The proposal, released May 18, defines adaptive trial designs as those that allow for prospectively planned modifications based on accumulating study data without detracting from the trial’s integrity or validity.

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