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。
In clinical trials, interim analyses are usually performed for ethical or economical reasons. Group sequential design quential design was the method of interim analysby ICH-GCP. The principle of group seand 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.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2006年第12期1433-1436,共4页
Chinese Journal of Clinical Pharmacology and Therapeutics
基金
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(№2002AA2Z341B)
关键词
成组序贯设计
期中分析
临床试验
重复测量
is
clinical trials
group sequential design
interim analys repeated measurement
