Multi-arm clinical trials of new agents: Some design considerations
Multi-arm clinical trials of new agents: Some design considerations
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DOI：
10.1158/1078-0432.ccr-08-0325
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发表时间：
2008-07-15
影响因子：
11.5
通讯作者：
Martin, Alison
中科院分区：
文献类型：
--
作者：
Freidlin, Boris;Korn, Edward L.;Martin, Alison
抗癌疗法开发的一个主要挑战是进行随机临床试验（RCT）需要大量的时间和资源。需要更有效的 RCT 设计来加速开发、最大限度地降低成本并使试验对患者更具吸引力。我们回顾了多臂设计的统计和逻辑特征，将几种实验治疗方法与常见的对照组进行了比较。特别是，我们提出了在为提高后勤效率而设计的多臂试验中不需要进行多重性调整的理由。相对于对每种实验药物进行单独的随机对照试验，这种多臂设计比多个双臂试验需要的总样本量要少。
A major challenge in the development of anticancer therapies is the considerable time and resources needed for conducting randomized clinical trials (RCT). There is a need for more efficient RCT designs that accelerate development, minimize costs, and make trials more appealing to patients. We review the statistical and logistical characteristics of multi-arm designs that compare several experimental treatments to a common control arm. In particular, we present a rationale for not requiring multiplicity adjustment in multi-arm trials that are designed for logistical efficiency. Relative to conducting separate RCTs for each experimental agent, this multi-arm design is shown to require a lower total sample size than multiple two-arm trials.