Noninferiority Trial Design

  • Mark Chang
Part of the Statistics for Biology and Health book series (SBH)


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).


Test Drug Draft Guidance Superiority Trial Noninferiority Trial Noninferiority Margin 
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Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  • Mark Chang
    • 1
  1. 1.BiometricsAMAG Pharmaceuticals, Inc.LexingtonUSA

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