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随机化是临床试验设计的重要环节,是保证试验组间均衡、减少偏倚的重要手段。作为一种动态随机化方法,最小随机化在基线因素影响较大的小样本量临床试验中有很大的优势,能起到均衡各组例数和重要预后因素的作用。文中主要阐述了最小随机化方法的基本过程,介绍了几种补充的实施方法,对最小随机化的一些重要的相关问题进行讨论。
Randomization is an important part of clinical trial design, which is an important means to ensure the balance between experimental groups and reduce the bias. As a dynamic randomization method, minimal randomization has great advantages in clinical trials of small sample size, which has a great influence on baseline factors, and can play a role of balancing the number of cases in each group and important prognostic factors. This paper mainly elaborates the basic process of the minimum randomization method, introduces several complementary implementation methods, and discusses some important related issues of minimum randomization.