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Modern Issues and Methods in BiostatisticsNoninferiority Trial Design

Modern Issues and Methods in Biostatistics: Noninferiority Trial Design [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).] http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png

Modern Issues and Methods in BiostatisticsNoninferiority Trial Design

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Publisher
Springer New York
Copyright
© Springer Science+Business Media, LLC 2011
ISBN
978-1-4419-9841-5
Pages
59 –86
DOI
10.1007/978-1-4419-9842-2_3
Publisher site
See Chapter on Publisher Site

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).]

Published: Jun 16, 2011

Keywords: Test Drug; Draft Guidance; Superiority Trial; Noninferiority Trial; Noninferiority Margin

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