Non-inferiority trials are used to test if a novel intervention is not worse than a standard treatment by more than a prespecified amount, the non-inferiority margin (ΔNI). The ΔNI indicates the amount of efficacy loss in the primary outcome that is acceptable in exchange for non-efficacy benefits in other outcomes. However, non-inferiority designs are sometimes used when non-efficacy benefits are absent. Without non-efficacy benefits, loss in efficacy cannot be easily justified. Further, non-efficacy benefits are scarcely defined or considered by trialists when determining the magnitude of and providing justification for the non-inferiority margin. This is problematic as the importance of a treatment’s non-efficacy benefits are critical to understanding the results of a non-inferiority study. Here we propose the routine reporting in non-inferiority trial protocols and publications of non-efficacy benefits of the novel intervention along with the reporting of non-inferiority margins and their justification. The justification should include the specific trade-off between the accepted loss in efficacy (ΔNI) and the non-efficacy benefits of the novel treatment and should describe whether patients and other relevant stakeholders were involved in the definition of the ΔNI.

非劣效性试验用于测试新干预措施是否比标准治疗差不超过预先指定的量，即非劣效性界限 (ΔNI)。ΔNI 表示主要结果中的有效性损失量是可接受的，以换取其他结果中的非有效性益处。然而，当不存在非效力收益时，有时会使用非劣效性设计。如果没有非疗效益处，就不能轻易证明疗效的损失是合理的。此外，试验者在确定非劣效性边际的大小并为其提供理由时，几乎没有定义或考虑非疗效益处。这是有问题的，因为治疗的非疗效益处的重要性对于理解非劣效性研究的结果至关重要。在这里，我们建议在非劣效性试验方案和出版物中常规报告新型干预措施的非疗效益处，以及非劣效性边际及其理由的报告。理由应包括可接受的疗效损失 (ΔNI) 与新疗法的非疗效益处之间的具体权衡，并应描述患者和其他相关利益相关者是否参与了 ​​ΔNI 的定义。