非劣效试验中对照的选择和界值确定方法

中国临床药理学与治疗学 ›› 2009, Vol. 14 ›› Issue (9): 961-965.

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非劣效试验中对照的选择和界值确定方法

马玉全, 周俊, 周爱平, 尹平

华中科技大学同济医学院公共卫生学院流行病与卫生统计学系, 武汉 430030, 湖北

收稿日期:2009-08-26 修回日期:2009-09-10 发布日期:2020-11-03
通讯作者: 尹平, E-mail: pingy2000@163.com
作者简介:马玉全, 男, 在读硕士研究生, 研究方向:生物统计学方法与应用。

Method of control selection and margin choice in non-inferiority trials

MA Yu-quan, ZHOU Jun, ZHOU Ai-ping, YIN Ping

Department of Epidemiology and Health Statistics, School of Public Health, TongjiMedical College, Huazhong University of Science &Technology, Wuhan 430030, Hubei, China

Received:2009-08-26 Revised:2009-09-10 Published:2020-11-03

摘要/Abstract

摘要： 非劣效试验是旨在显示试验药物的治疗效果在临床上不比阳性对照药物差的一种设计类型。近年来, 由于安慰剂对照试验受到伦理学方面的限制, 以及阳性药物的大量存在, 使得非劣效试验设计得到了广泛的应用。但是, 遗憾的是在目前还没有一个完善的指导原则的情况下, 一些非劣效试验设计存在着包括适用条件不符合、阳性对照选择错误、界值的确定不合理等诸多问题。为此, 本文结合国外的一些研究着重就非劣效试验中对照的选择和界值的确定进行总结和讨论,以期为在国内正确使用临床非劣效试验的设计提供参考。

关键词: 非劣效试验, 对照, 界值

Abstract: Non-inferiority trial is a type of design which can show that the clinical effect of the experimented medicine is no worse than the active control medicine. In the recent years, owing to the ethical limit of placebo-controlled trail and existence of many active medicines, non-inferiority trial designs have been widely used. Unfortunately, some non-inferiority trial designs have many flaws because of the lack of the golden rules, including disaccord to the applied condition, incorrect selection of the active control, irrationality of the margin conformation and etc. In this paper, control selection and margin choice are discussed and summarized mostly, combining with many overseas researches, in order to provide some suggestions to the design and practice of non-inferiority trial in our country.

Key words: non-inferiority trial, comparator, margin

中图分类号:

R969

马玉全, 周俊, 周爱平, 尹平. 非劣效试验中对照的选择和界值确定方法[J]. 中国临床药理学与治疗学, 2009, 14(9): 961-965.

MA Yu-quan, ZHOU Jun, ZHOU Ai-ping, YIN Ping. Method of control selection and margin choice in non-inferiority trials[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2009, 14(9): 961-965.

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非劣效试验中对照的选择和界值确定方法

Method of control selection and margin choice in non-inferiority trials

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