各参数配置对随机化胜者优先原则组间分配比例的影响

中国临床药理学与治疗学 ›› 2011, Vol. 16 ›› Issue (10): 1137-1141.

各参数配置对随机化胜者优先原则组间分配比例的影响

于莉莉¹, 李霞¹, 步晓冬², 刘召平¹, 夏结来³

¹济南军区总医院信息科统计室, ²科训科, 济南 250031,山东;
³第四军医大学卫生统计学教研室,西安 710032,陕西

收稿日期:2011-06-17 修回日期:2011-08-18 出版日期:2011-10-26 发布日期:2011-11-02
作者简介:于莉莉,女,博士,主管技师,主要从事医院病案统计与临床科研统计工作。Tel: 0531-51666924, E-mail: lili198012@sohu.com
基金资助:
国家自然科学基金课题(81072390)

Effects of some parameters of randomized play the winner rule on allocation proportions in clinical trial

YU Li-li¹, LI Xia¹, BU Xiao-dong², LIU Zhao-ping¹, XIA Jie-lai³

¹Department of Information Technology, the General Hospital of Jinan Military Command, ²Department of Science Research and Training, the General Hospital of Jinan Military Command, Jinan 250031, Shandong, China;
³Department of Health Statistics, Faculty of Preventative Medicine, the Fourth Military Medical University, Xi'an 710032, Shaanxi, China

Received:2011-06-17 Revised:2011-08-18 Online:2011-10-26 Published:2011-11-02

摘要/Abstract

摘要： 随机化胜者优先原则是适应性设计的一种最基本最常用的随机化方法。本文通过计算机抽样模拟实验对随机化胜者优先规则(RPW)原则中各参数对分配比例的影响进行了探索研究。结果发现,u对于分配比例的影响呈负反馈,a呈正反馈,而b对于分配比例的影响最值得关注,初始时b的增加会使得两组分配比例的差距缩小,而增加到一定程度后,则对分配的比例的影响甚微。同时,模拟验证了两组的成功率大小对于分配比例的影响。通过以上的分析验证,希望为RPW原则在新药临床研究中的实际应用提供参考。

关键词: 适应性设计, 随机化胜者优先原则, 模拟实验

Abstract: RPW rule is a most commonly used randomization method of adaptive design. In this article, the influence of three parameters of RPW(u,a,b) rule on the treatment allocation proportion by means of Monte Carlo simulation were explored. The results indicated that the difference of allocation proportions between two treatment groups decreases with the increase of u value and trend towards zero when u become very large. However parameter a has an inverse influence of that of u. Compared with parameter a and u, the influence of parameter b is more complex, the difference of allocation proportions between two treatment groups increases as b increases, but the extent of this influence is too low to be concerned. In addition, the treatment allocation proportions were investigated through computer simulation experiment under different situations of treatment successful probabilities. We hope this study can provide some references for the application of RPW rule in practical clinical trials.

Key words: Adaptive design, Randomized play the winner rule, Simulation examination

中图分类号:

R969

于莉莉, 李霞, 步晓冬, 刘召平, 夏结来. 各参数配置对随机化胜者优先原则组间分配比例的影响[J]. 中国临床药理学与治疗学, 2011, 16(10): 1137-1141.

YU Li-li, LI Xia, BU Xiao-dong, LIU Zhao-ping, XIA Jie-lai. Effects of some parameters of randomized play the winner rule on allocation proportions in clinical trial[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2011, 16(10): 1137-1141.

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