Recent FDA draft guidance for sponsors of oncology clinical trials encourages enrolment of patients with incurable cancer and no potential for prolonged and/or near-normal survival,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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FDA 扩大肿瘤学试验资格的最新举措——一把双刃剑？

FDA 最近针对肿瘤临床试验赞助商的指南草案鼓励招募患有无法治愈的癌症且没有延长和/或接近正常生存潜力的患者，无论他们是否接受了现有的治疗选择。该指南与当前标准存在重大差异，对试验参与者以及药物监管和报销具有潜在的深远影响。