FDA Opens Public Comments for Draft Guidance on External Controls in Clinical Trials

The US Food and Drug Administration (FDA) is seeking comments for its newly released draft guidance on using external controls in clinical trials, a move that comes as the agency is increasingly relying on real-world evidence (RWE) for regulatory decision-making. Comments must be submitted by May 2^nd, 2023 to be considered during the development of the final guidance.

According , “Externally controlled trials can be useful when it would not be feasible or ethical to use an internal control in the study, such as in studies of populations with rare diseases. The FDA issued the draft guidance as part of a series of guidance documents under its Real-World Evidence Program to satisfy a mandate under the 21st Century Cures Act.”

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(Source: FDA, January 31^st, 2023)