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Through the looking glass: understanding non-inferiority

Jennifer Schumi* and Janet T Wittes

Author Affiliations

Statistics Collaborative, Inc., Suite 600, 1625 Massachusetts Avenue NW, Washington DC 20036, USA

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Trials 2011, 12:106  doi:10.1186/1745-6215-12-106

Published: 3 May 2011


Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use. This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United States Food and Drug Administration.