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Review
. 2011 May 3:12:106.
doi: 10.1186/1745-6215-12-106.

Through the looking glass: understanding non-inferiority

Jennifer Schumi  1 , Janet T Wittes
Affiliations
Review

Through the looking glass: understanding non-inferiority

Jennifer Schumi et al. Trials. .

Abstract

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.

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Figures

Figure 1
Figure 1
The role of Δ in superiority, equivalence and non-inferiority trials.
Figure 2
Figure 2
Possible outcomes of a non-inferiority trial.
Figure 3
Figure 3
A forest plot and M1.
Figure 4
Figure 4
M2 as a fraction of M1.
See this image and copyright information in PMC

References

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