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The FDA’s latest move to expand eligibility for oncology trials — a double-edged sword?

Recent FDA draft guidance for sponsors of oncology clinical trials encourages enrolment of patients with incurable cancer and no potential for prolonged and/or near-normal survival, regardless of whether they have received existing treatment options. This guidance constitutes a substantial departure from current standards, with potentially profound implications for trial participants as well as drug regulation and reimbursement.

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Corresponding author

Correspondence to Vinay Prasad.

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Competing interests

V.P. has received research funding from Arnold Ventures, royalties from the Johns Hopkins Press, Speaker’s fees from Evicore, and honoraria from Medscape and from various universities, medical centres, non-profit organizations and professional societies. V.P. has also acted as a consultant of UnitedHealthcare, and his Plenary Session podcast has Patreon backers. M.P.L. declares no competing interests.

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Lythgoe, M.P., Prasad, V. The FDA’s latest move to expand eligibility for oncology trials — a double-edged sword?. Nat Rev Clin Oncol (2021).

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