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Modern Issues and Methods in Biostatistics pp 59–86Cite as

Noninferiority Trial Design

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Part of the book series: Statistics for Biology and Health ((SBH))

Abstract

Superiority and noninferiority (NI) trials are two common types of clinical trials. Superiority means, in layman’s language, that the test drug is better than the comparative drug (active comparator or active-control), whereas noninferiority suggests that the test drug may not be as good as the comparative drug, but the difference is not clinically significant. If a test drug is noninferior to an active-control, it must be at least superior to a placebo (Fig. 3.1).

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Authors and Affiliations

  1. Biometrics, AMAG Pharmaceuticals, Inc., Hayden Ave. 100, 02421, Lexington, Massachusetts, USA

    Mark Chang

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Chang, M. (2011). Noninferiority Trial Design. In: Modern Issues and Methods in Biostatistics. Statistics for Biology and Health. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-9842-2_3

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