模拟探索临床试验中瓮模型对检验效能的影响

中国临床药理学与治疗学 ›› 2013, Vol. 18 ›› Issue (3): 286-289.

模拟探索临床试验中瓮模型对检验效能的影响

于莉莉¹, 步晓冬², 顾欣¹, 杜倩¹, 夏结来³

¹济南军区总医院信息科病案统计室
²医务部科训科,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:2012-04-28 修回日期:2012-11-30 出版日期:2013-03-26 发布日期:2013-04-02
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

Explore on the effects of General Friedman's Urn Model on power in clinical trial through simulation experiments

YU Li-li¹, BU Xiao-dong², GU Xin¹, DU Qian¹, XIA Jie-lai³

¹Department of Information Technology
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:2012-04-28 Revised:2012-11-30 Online:2013-03-26 Published:2013-04-02

摘要/Abstract

摘要： 目的: 广义Friedman's瓮模型是适应性设计的一种最基本最常用的随机化方法。本文依据某一治疗复发性口疮的真实临床试验数据通过计算机模拟实现了其反应变量-适应性随机化,并对反应变量-适应性随机化所得的组间分配比例对检验效能的影响作了初步探讨与验证。模拟结果显示各处理组间的非等比例分配并没有使得检验效能有所降低。由此可推断,对于大多数临床试验来说,瓮模型产生的不均衡分配比例一般小于3∶1,其对检验效能的影响非常有限。通过以上的分析验证,希望为瓮模型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, 瓮模型, 模拟实验

Abstract: Urn model is a most commonly used randomization method of adaptive design. In this article, with some true data from the clinical trial of a new drug treating oral ulcer, the generalized Friedman's urn model was used to calculate the allocation proportions between the two treatments groups, and simultaneously, the influence of the allocation proportions on the power of statistical test were explored trough computer simulation experiments. It was showed in the results that the effects of response adaptive randomization on power was not as serious as we assumed, because the allocation proportions between the two treatments groups is usually less than 3∶1 for most clinical trials. We hope this study can provide some references for the application of urn model in practical clinical trials.

Key words: Adaptive design, Urn model, Simulation examination

中图分类号:

R311

于莉莉, 步晓冬, 顾欣, 杜倩, 夏结来. 模拟探索临床试验中瓮模型对检验效能的影响[J]. 中国临床药理学与治疗学, 2013, 18(3): 286-289.

YU Li-li, BU Xiao-dong, GU Xin, DU Qian, XIA Jie-lai. Explore on the effects of General Friedman's Urn Model on power in clinical trial through simulation experiments[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2013, 18(3): 286-289.

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[2]	于莉莉, 步晓冬, 刘召平, 李霞, 夏结来. 临床试验中访视时间与入组速度对瓮模型组间分配比例的影响[J]. 中国临床药理学与治疗学, 2011, 16(5): 506-509.
[3]	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.
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