Recent FDA draft guidance for sponsors of oncology clinical trials encourages enrolment of patients with incurable cancer and no potential for prolonged and/or near-normal survival,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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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). https://doi.org/10.1038/s41571-021-00559-0