New FDA guidance updates clinical trials for accelerated oncology drug approval

The FDA issued draft guidance for clinical trials of oncology drugs in the accelerated approval application.

The draft guidance outlines the design of clinical trials in order to reduce clinical uncertainty and improve data available at the time of approval, according to a March 24 FDA release. Two randomized clinical trial approaches are recommended: conducting two separate randomized controlled clinical trials or using one trial for both accelerated approval and to verify clinical benefit. These trial formats provide greater benefits, compared to the single-arm trials, in appropriate cases, according to the release.

"Today's draft guidance provides recommendations to sponsors for designing clinical trials to support accelerated approval," Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence, said in the release. "Building quality and efficiency into the design of oncology clinical trials is a crucial component in providing maximum benefit to those living with cancer."

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