简单介绍成组序贯设计在临床试验中的应用

中国临床药理学与治疗学 ›› 2006, Vol. 11 ›› Issue (12): 1433-1436.

简单介绍成组序贯设计在临床试验中的应用

李先涛, 梁伟雄¹, 张伯礼

天津中医药大学中医药研究中心, 天津 300193;
¹广州中医药大学DME 中心, 广州 510405, 广东

收稿日期:2006-09-15 修回日期:2006-10-30 出版日期:2006-12-26 发布日期:2020-11-06
通讯作者: 梁伟雄,男, 教授, 博士生导师, 主要从事临床流行病学、神经病学的研究。Tel:020-36585404 　E-mail:Liangwx@public.guangzhou.gd.cn
作者简介:李先涛, 男, 博士, 副研究员, 研究方向:临床流行病学应用。Tel:13682001864 E-mail:lxt150@126.com
基金资助:
国家高技术研究发展计划基金项目(863 计划):临床试验关键技术及平台研究(No2002AA2Z341B)

Simply introduced the application of grouPsequential design in clinical test

LI Xian-tao, LIANG Wei-xiong¹, ZHANG Bo-li

Research Center of TCM, Tianjin University of TCM, Tianjin 300193, China;
¹DME Center, Guangzhou University of TCM, Guangzhou 510407, Guangdong, China

Received:2006-09-15 Revised:2006-10-30 Online:2006-12-26 Published:2020-11-06

摘要/Abstract

摘要： 在临床试验中, 常常因为伦理或经济的原因需要进行期中分析, 成组序贯设计是ICH-GCP推荐的期中分析方法。本文对该方法的原理及其在临床试验中的几个问题:期中分析的次数、检验界值、样本估算和终点指标的影响等进行了简单介绍。

关键词: 成组序贯设计, 期中分析, 临床试验, 重复测量

Abstract: In clinical trials, interim analyses are usually performed for ethical or economical reasons.GrouPsequential design was the method of interim analysis recommended by ICH-GCP.The principle of grouPsequential design and its several questions:times of interim analysis, the value of statistic test, the sample estimate,selection of endpoints and others were introduced in this article.

Key words: grouPsequential design, interim analysis, clinical trials, repeated measurement

中图分类号:

R969.4

李先涛, 梁伟雄, 张伯礼. 简单介绍成组序贯设计在临床试验中的应用[J]. 中国临床药理学与治疗学, 2006, 11(12): 1433-1436.

LI Xian-tao, LIANG Wei-xiong, ZHANG Bo-li. Simply introduced the application of grouPsequential design in clinical test[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2006, 11(12): 1433-1436.

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