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FDA Backs Randomized Trials for Accelerated Drug Approval

April 7, 2023

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In an important update to its policies for conducting clinical trials to support accelerated approval of important oncology and other lifesaving therapies, FDA is articulating a preference for randomized controlled trials (RCTs), as opposed to single-arm studies, to support fast approvals of breakthrough drugs. A new draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics was published on March 24, 2023. The document discusses ways to reduce “clinical uncertainty for patients” by encouraging sponsors to conduct RCTs to support accelerated approval. “Building quality and efficiency into the design of oncology clinical trials is a crucial component in providing maximum benefit to those living with cancer,” stated Oncology Center of Excellence (OCE) Director Richard Pazdur.

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