The pursuit of balance: An overview of covariate-adaptive randomization techniques in clinical trials
The pursuit of balance: An overview of covariate-adaptive randomization techniques in clinical trials
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DOI：
10.1016/j.cct.2015.07.011
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发表时间：
2015-11-01
影响因子：
2.2
通讯作者：
Su, Zheng
中科院分区：
文献类型：
--
作者：
Lin, Yunzhi;Zhu, Ming;Su, Zheng
随机化是临床试验设计和实施的基础。简单随机化可确保受试者治疗分配的独立性，并防止潜在的选择偏倚，但不能保证治疗组间协变量分布的平衡。出于多种原因，需要确保治疗组间重要预后协变量的平衡。本文综述了实现平衡的一类广泛的随机化方法，包括区组随机化、分层随机化、最小化和动态分层随机化。实际考虑所产生的经验与使用的技术进行了说明。还提供了最近随机临床试验中实际使用的随机化方法的综述。(C)2015 Elsevier Inc. All rights reserved.
Randomization is fundamental to the design and conduct of clinical trials. Simple randomization ensures independence among subject treatment assignments and prevents potential selection biases, yet it does not guarantee balance in covariate distributions across treatment groups. Ensuring balance in important prognostic covariates across treatment groups is desirable for many reasons. A broad class of randomization methods for achieving balance are reviewed in this paper; these include block randomization, stratified randomization, minimization, and dynamic hierarchical randomization. Practical considerations arising from experience with using the techniques are described. A review of randomization methods used in practice in recent randomized clinical trials is also provided. (C) 2015 Elsevier Inc. All rights reserved.