Noninferiority trials in oncology assess novel therapies with the potential for slightly worse recurrence or death outcomes (ie, the margin of noninferiority) than standard therapies. This poses a dilemma because, in the absence of potential health outcome advantages, these trials may not provide the treatment equipoise required for an ethical study. Any new treatment with the potential for slightly worse recurrence or death outcomes should have countervailing health outcome advantages, but these are rarely taken into account in the design of noninferiority trials. This article presents the argument that not only the potentially worse health outcomes but also the potential benefits of the novel therapy should be considered when designing, analyzing, and reporting noninferiority trials. Some approaches to study design and analysis that consider both primary and secondary end points are discussed, and reporting the joint distributions of end points for the novel and standard treatments is recommended.

肿瘤学中的非劣效性试验评估的新型疗法与标准疗法相比，其复发或死亡结果（即非劣效性的余地）的潜力可能会稍差一些。这造成了一个难题，因为在没有潜在的健康结果优势的情况下，这些试验可能无法提供伦理研究所需的治疗平衡。任何可能使复发或死亡结果稍差的新疗法均应具有与健康结果相反的优势，但在非劣效性试验的设计中很少考虑到这些优势。本文提出的论点是，在设计，分析和报告非劣效性试验时，不仅应考虑潜在的较差的健康结果，而且应考虑新疗法的潜在益处。