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Oncology Drug Development in Focus: FDA Offers Recommendations for Clinical Trial Designs to Support Accelerated Approval

On March 24, 2023, FDA published a draft guidance entitled “Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics” that describes recommendations to promote quality data and efficiency of clinical trials for novel oncology drugs. Notably, the guidance places renewed emphasis on the use of randomized controlled trials (“RCTs”) in lieu of single-arm trials that have commonly been used to support accelerated approvals in the past. This Alert summarizes FDA’s recommendations in the new draft guidance for the design and analysis of clinical trials and the implications for sponsors developing oncology drugs under the accelerated approval pathway.

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