The pros and cons of noninferiority trials

Author: Pocock S.J.

Source: Fundamental & Clinical Pharmacology, Volume 17, Number 4, August 2003 , pp. 483-490(8)

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

Document Type: Research article

DOI: http://dx.doi.org/10.1046/j.1472-8206.2003.00162.x

Affiliations: 1: Medical Statistics Unit, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT UK

Publication date: 2003-08-01