The pros and cons of noninferiority trials

被引：91

作者：

Pocock, SJ ^{[1
]}

机构：

[1] Univ London London Sch Hyg & Trop Med, Dept Epidemiol & Populat Hlth, Med Stat Unit, London WC1E 7HT, England

来源：

FUNDAMENTAL & CLINICAL PHARMACOLOGY | 2003年 / 17卷 / 04期

关键词：

control groups; equivalence; ethics; noninferiority; randomized clinical trials; trial size;

D O I：

10.1046/j.1472-8206.2003.00162.x

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Noninferiority trials comparing new treatment with an active standard control are becoming increasingly common. This article discusses relevant issues regarding their need, design, analysis and interpretation: the appropriate choice of control group. types of noninferiority trial, ethical considerations, sample size determination and potential pitfalls to consider.

引用

收藏

页码：483 / 490

页数：8

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