FDA’s Draft Guidance on Externally Controlled Trials Answers Some Questions, Leaves Others Unanswered
FDA Law Blog
APRIL 23, 2023
The Draft Guidance recommends that, where possible, the outcome should be assessed by individuals blinded to treatment status, which may require re-adjudication of externally controlled data. Sponsors should also propose additional analyses to evaluate the comparability between the trial arms for important covariates.
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