临床试验最小随机化的方法概况和研究前景  

Introduction and prospection of minimization random on clinical trials

作　　者：吴春芳[1] 许金芳[1] 陆健[1] 吴美京[1] 贺佳[1] 

机构地区：[1]第二军医大学卫生统计学教研室,上海200433

出　　处：《中国新药杂志》2010年第10期823-826,831,共5页Chinese Journal of New Drugs

基　　金：重大新药创制重大专项新药临床研究技术平台建设(2008ZX09312-007和2008ZX09312-025)

摘　　要：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 one of the most important aspects of clinical trial design,which is a good way to avoid bias in trials.As a dynamic randomization method,minimization random plays an unparalleled role in small heterogeneous trials,making well-balanced treatment groups with regard of patient numbers and important prognostic factors.The aims of this paper were to describe the basic process of minimization random,introduce some supplementary methods,summarize some related issues and also discuss the prospect of its future development.

关 键 词：最小随机化 均衡性 随机因素 预后因素 

分 类 号：R95[医药卫生—药学]