期刊
CONTEMPORARY CLINICAL TRIALS
卷 45, 期 -, 页码 21-25出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2015.07.011
关键词
Clinical trials; Randomization; Block randomization; Stratified randomization; Minimization; Dynamic hierarchical randomization
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.
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