The Food and Drug Administration is eyeing policy changes that could make drugmakers conduct more stringent trials to win fast-track approvals of cancer drugs.
treatments be put through randomized controlled trials, in which drugmakers measure the effectiveness of an experimental treatment against a conventional one, instead of widely used "single-arm studies" that lack a comparison.
Single-arm studies would be limited to specific instances, and companies would be encouraged to discuss with FDA in advance whether the expected effect is reasonably likely to predict clinical benefit. "Given the limitations of single-arm trials, a randomized controlled trial is the preferred approach to support an application for accelerated approval," the FDA wrote in draft guidance.Separate randomized trials to support the accelerated approval of the drug and to then verify its clinical benefit, or a single randomized trial with short and longer-term endpoints.
The comment period on the guidance runs through May 26, PhRMA, the big drug industry trade group, declined comment on Monday when asked about the draft.
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