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. 2003 Aug;17(4):483-90.
doi: 10.1046/j.1472-8206.2003.00162.x.

The pros and cons of noninferiority trials

Stuart J Pocock  1
Affiliations

The pros and cons of noninferiority trials

Stuart J Pocock. Fundam Clin Pharmacol. 2003 Aug.

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.

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