A systematic review of noninferiority margins in oncology clinical trials

被引：3

作者：

Hashim, Mahmoud ^{[1
]}

Vincken, Talitha ^{[1
]}

Kroi, Florint ^{[1
]}

Gebregergish, Samron ^{[1
]}

Spencer, Mike ^{[2
]}

Wang, Jianping ^{[2
]}

Kampfenkel, Tobias ^{[3
]}

Lam, Annette ^{[2
]}

He, Jianming ^{[2
]}

机构：

[1] Ingress Hlth, NL-3012 NJ Rotterdam, Netherlands

[2] Janssen Global Serv LLC, Raritan, NJ 08869 USA

[3] Janssen Res & Dev LLC, NL-2333 CB Leiden, Netherlands

来源：

JOURNAL OF COMPARATIVE EFFECTIVENESS RESEARCH | 2021年 / 10卷 / 06期

关键词：

cancer; noninferiority clinical trial; noninferiority margin; oncology; randomized controlled trial; systematic literature review; EQUIVALENCE RANDOMIZED-TRIALS; NON-INFERIORITY MARGINS; CELL LUNG-CANCER; EXTENSION; DESIGN;

D O I：

10.2217/cer-2020-0200

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Aim: A systematic literature review was conducted to identify and characterize noninferiority margins for relevant end points in oncology clinical trials. Materials & methods: Randomized, controlled, noninferiority trials of patients with cancer were identified in PubMed and Embase. Results: 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). Conclusion: 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.

引用

页码：443 / 455

页数：13

共 21 条

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