The pros and cons of noninferiority trials
- 7 July 2003
- journal article
- website
- Published by Wiley in Fundamental & Clinical Pharmacology
- Vol. 17 (4) , 483-490
- https://doi.org/10.1046/j.1472-8206.2003.00162.x
Abstract
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.Keywords
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