Through the looking glass: understanding non-inferiority

被引：327
作者：
Schumi, Jennifer [1 ]
Wittes, Janet T. [1 ]
机构：
[1] Stat Collaborat Inc, Washington, DC 20036 USA
来源：
TRIALS | 2011年 / 12卷
关键词：
PLACEBO-CONTROLLED TRIALS; ACTIVE-CONTROL TRIALS; RANDOMIZED TRIALS; ISSUES; NONINFERIORITY;
D O I：
10.1186/1745-6215-12-106
中图分类号：
R-3 [医学研究方法]; R3 [基础医学];
学科分类号：
1001 ;
摘要：
Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use. This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United States Food and Drug Administration.
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页数：12
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