Freidlin Boris, Korn Edward L
Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD.
JCO Oncol Pract. 2024 Dec;20(12):1555-1558. doi: 10.1200/OP.24.00217. Epub 2024 Jul 10.
In a randomized clinical trial, instead of allocating patients equally between the treatment arms, some trials in oncology assign a higher proportion of patients to receive the experimental treatment arm (eg, a two-to-one randomization). In this commentary, we first briefly review the common reasons given for the use of a two-to-one randomization and provide some examples of trials using these designs. We then explain why the risk-benefit ratio of this approach may not be favorable as is commonly assumed.
在一项随机临床试验中,肿瘤学领域的一些试验并非在各治疗组间平均分配患者,而是将更高比例的患者分配至接受试验性治疗组(例如,二比一随机分组)。在本评论中,我们首先简要回顾使用二比一随机分组的常见理由,并提供一些采用这些设计的试验实例。然后我们解释为何这种方法的风险效益比可能并不像通常所认为的那样有利。