响应-自适应随机化分组方法

中国临床药理学与治疗学 ›› 2008, Vol. 13 ›› Issue (6): 684-689.

响应-自适应随机化分组方法

刘晓燕, 陈峰, 魏永越, 柏建岭, 于浩

南京医科大学流行病与卫生统计学系, 南京 210029, 江苏

收稿日期:2008-05-12 修回日期:2008-05-23 发布日期:2020-10-14
通讯作者: 于浩,女,博士,教授,硕士生导师,研究方向:临床试验中的统计方法与规范化。Tel:025-86862934 E-mail:njyuhao@vip.sina.com
作者简介:刘晓燕,女,硕士,研究方向:临床试验中的统计方法与规范化。Tel:13915976729 E-mail:xyliumail@gmail.com

Response-adaptive randomization in clinical trials

LIU Xiao-yan, CHEN Feng, WEI Yong-yue, BAI Jian-ling, YU Hao

Department of Epidemiology and Biostatistics, Nanjing Medical University, Nanjing 210029, Jiangsu, China

Received:2008-05-12 Revised:2008-05-23 Published:2020-10-14

摘要/Abstract

摘要： 目的: 介绍临床试验中一种随机化分组方法——响应-自适应随机化分组方法。方法: 结合模拟实验,介绍响应-自适应随机化分组方法中“胜者优先原则”和“随机化胜者优先原则”的思想和原理,并讨论响应-自适应随机化分组方法的优缺点及应用中需注意的问题。结果: 模拟结果显示,与传统的等比例分配结果相比,随机化胜者优先原则可以减少临床试验中的失败人数,而检验效能降低很少。结论: 与传统等比例分配相比,响应-自适应随机化分组方法更好地兼顾了伦理问题,值得临床界及统计学界重视,完善后可推荐在临床试验中应用。

关键词: 随机化胜者优先原则, 罐子模型, 响应-自适应随机化设计, 临床试验

Abstract: AIM: To introduce the response-adaptive randomization, which is one of the randomization strategies in clinical trials.METHODS: The ideas and theories of the play-the-winner rule and randomized-play-the-winner rule, which are two procedures of response-adaptive randomization, are introduced.A simulation study is employed to compare response-adaptive randomization with traditional equal-probability allocation.The advantages and disadvantages of the randomization rules and the issues concerned in implementation of response-adaptive randomization are discussed.RESULTS: The results show that the response-adaptive randomization reduce the number of failures with little decrease in test power than in the case of traditional equal-probability allocation.CONCLUSION: The play-the-winner rule and randomizedplay-the-winner rule deserve the attention of clinicians and statisticians and are suggested in clinical trials after a certain degree of improvement since it is better balanced of the issues between ethics and statistics.

Key words: randomized-play-the-winner rule, urn model, response-adaptive randomization, clinical trial

中图分类号:

R969

刘晓燕, 陈峰, 魏永越, 柏建岭, 于浩. 响应-自适应随机化分组方法[J]. 中国临床药理学与治疗学, 2008, 13(6): 684-689.

LIU Xiao-yan, CHEN Feng, WEI Yong-yue, BAI Jian-ling, YU Hao. Response-adaptive randomization in clinical trials[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2008, 13(6): 684-689.

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