摘要
目的:本文介绍一种新的多阶段随机化胜者优先原则,以便自适应随机分组方法在临床试验中的应用。方法:采用计算机模拟试验,探讨传统随机分组方法、改良随机化胜者优先原则及多阶段随机化胜者优先原则对检验效能及平均减少失败人数的影响。结果:尽管改良随机化胜者优先原则和多阶段随机化胜者优先原则的检验效能低于传统方法,但相差不大。改良随机化胜者优先原则对于平均减少失败人数的调整力度最强,随着调整分组概率时间间隔的延长,多阶段随机化胜者优先原则对于平均减少失败人数的改变逐渐减弱。在不同率及率差水平下,平均减少失败人数呈现一定的趋势:率差较小时,成功率影响较大,时间间隔影响较小;率差较大时,成功率影响较小,时间间隔影响较大。结论:多阶段随机化胜者优先原则兼顾了改良随机化胜者优先原则的优点,同时扩展了改良随机化胜者优先原则的实际可操作性。但在组间率差较大时,使用多阶段随机化胜者优先原则要选择合理的时间间隔。
AIM：To present an adaptive randomized method,multi-stage randomized-play-the-winner rule（MSRPW）,which facilitates the application of adaptive randomization in clinical trial.METHODS：By using the simulation study,we compared the powers and the mean reduced failures of three different methods,those were traditional equal-probability random allocation,modified randomized-play-the-winner rule and multi-stage randomized-play-the-winner rule.RESULTS：Compared with traditional allocation method,both MRPW and MSRPW could reduced failures in clinical trials,although their powers were decreased slightly.The MRPW reduced the most failures in all scenarios,MSRPW performed as well as MRPW in the scenarios when the difference of effects of test and control groups was not large,or the time interval of adjusting allocation probability was not long,while the traditional allocation performed worst.With the time interval prolonging,MSRPW reduced fewer and fewer failures than MRPW.CONCLUSION：The MSRPW rule proposed in this paper takes both advantages of traditional randomization and MRPW rule into consideration,and more practical than MRPW in clinical trials.MSRPW can be very useful in those scenarios when the difference of effects of the test and control groups is moderate or small,while an appropriate time interval should be chosen carefully when the difference of effects is large.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2010年第8期888-893,共6页
Chinese Journal of Clinical Pharmacology and Therapeutics
基金
江苏省自然科学基金"临床试验中的优化设计与统计分析方法研究"资助(BK2008449)
