Ingress-Health, Rotterdam, NJ 3012, Netherlands.
Janssen Global Services, LLC, Raritan, NJ 08869, USA.
J Comp Eff Res. 2021 Apr;10(6):443-455. doi: 10.2217/cer-2020-0200. Epub 2021 Mar 17.
A systematic literature review was conducted to identify and characterize noninferiority margins for relevant end points in oncology clinical trials. Randomized, controlled, noninferiority trials of patients with cancer were identified in PubMed and Embase. Of 2284 publications identified, 285 oncology noninferiority clinical trials were analyzed. The median noninferiority margin was a hazard ratio of 1.29 (mean: 1.32; range: 1.05-2.05) for studies that reported time-to-event end points (n = 192). The median noninferiority margin was 13.0% (mean: 12.7%; range: 5.0-20.0%) for studies that reported response end points as absolute rate differences (n = 31). Although there was consistency in the noninferiority margins' scale, variability was evident in noninferiority margins across trials. Increased transparency may improve consistency in noninferiority margin application in oncology clinical trials.
进行了系统的文献回顾，以确定并描述肿瘤学临床试验中相关终点的非劣效性边界。在 PubMed 和 Embase 中确定了癌症患者的随机对照非劣效性试验。在确定的 2284 篇文献中，分析了 285 项肿瘤学非劣效性临床试验。报告时间事件终点的研究中（n=192），非劣效性边界的中位数为风险比 1.29（均值：1.32；范围：1.05-2.05）。报告作为绝对率差异的反应终点的研究中（n=31），非劣效性边界的中位数为 13.0%（均值：12.7%；范围：5.0-20.0%）。尽管非劣效性边界的尺度具有一致性，但在试验之间的非劣效性边界存在明显的可变性。增加透明度可能会提高肿瘤学临床试验中非劣效性边界应用的一致性。
