期中分析在药物临床试验中的价值

中国临床药理学与治疗学 ›› 2005, Vol. 10 ›› Issue (1): 112-115.

期中分析在药物临床试验中的价值

李先涛, 梁伟雄, 王奇, 温泽淮

广州中医药大学DME 中心, 广州 510405, 广东

收稿日期:2004-12-07 修回日期:2005-01-11 出版日期:2005-01-26 发布日期:2020-11-19
通讯作者: 梁伟雄, 男, 教授, 博士生导师, 主要研究方向:临床流行病学和神经病学。Tel:020-36585404 E-mail:Liangwx@public.guangzhou.gd.cn
作者简介:李先涛, 男, 博士研究生, 主要研究方向:临床流行病学应用。Tel:020-36585404 E-mail:Lsn150@sohu.com/Lusuna@gdut.edu.cn
基金资助:
国家高技术研究发展计划(863 计划)临床试验关键技术及平台研究(No2002AA2Z341B)

Values of interim analysis in drug clinical trials studies

LI Xian-tao, LIANG Wei-xiong, WANG Qi, WEN Ze-huai

DME Center, Guangzhou University of TCM, Guangzhou 510405, Guangdong, China

Received:2004-12-07 Revised:2005-01-11 Online:2005-01-26 Published:2020-11-19

摘要/Abstract

摘要： 期中分析是指在一个临床试验正式完成之前的任何时间内, 为了比较组间的有效性和或安全性而进行的分析。在新药开发中, 期中分析被认为是一种有力的工具。期中分析的目的是及早终止试验。如果出现以下几种情况即可做出停止试验的决定:所研究药物的有效性已清楚;预期的组间效应差异不可能达到;出现了无法耐受的药物不良反应。期中分析现已被广泛用于大规模的临床试验中, 如果Ⅰ型错误或检验效能没有降低, 且能比固定样本设计节省30 %～40 %的样本量, 能够有效控制偏倚, 对保证临床试验结果的真实性起着重要的作用。

关键词: 临床试验, 期中分析, 数据与安全监测组, 药物不良反应, 固定样本设计

Abstract: An interim analysis is any analysis intended to compare the efficacy or safety at any time before formal completion of a trial, and it is seen as a powerful tool in new drug development.The goal of an interim analysis is to stop the trial early if the superiority of the treatment under study is clearly established, or if the demonstration of a relevant treatment difference has become unlikely, or if unacceptable adverse effects are apparent.Interim analysis design has been widely and successfully used in large, long-term trials, and it can prevent certain types of bias and result in a 30 to 40 percent reduction in average sample size with no appreciable decrease in type I error or power.

Key words: clinical trial, interim analysis, data safety monitoring board(DSMB), adverse drug reaction (ADR), fixed sample design

中图分类号:

R311

李先涛, 梁伟雄, 王奇, 温泽淮. 期中分析在药物临床试验中的价值[J]. 中国临床药理学与治疗学, 2005, 10(1): 112-115.

LI Xian-tao, LIANG Wei-xiong, WANG Qi, WEN Ze-huai. Values of interim analysis in drug clinical trials studies[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2005, 10(1): 112-115.

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