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Fundam Clin Pharmacol. 2003 Aug;17(4):483-90.

The pros and cons of noninferiority trials.

Author information

1
Medical Statistics Unit, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT UK. stuart.pocock@lshtm.ac.uk

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.

PMID:
12914552
[Indexed for MEDLINE]

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