Title

Testing of non-inferiority and superiority for three-arm clinincal studies with multiple experimental treatments

Publication Type

Journal Article

Publication Date

9-2016

Abstract

The purpose of a non-inferiority trial is to assert the efficacy of an experimental treatment compared with a reference treatment by showing that the experimental treatment retains a substantial proportion of the efficacy of the reference treatment. Statistical methods have been developed to test multiple experimental treatments in three-arm non-inferiority trials. In this paper, we report the development of procedures that simultaneously test the non-inferiority and the superiority of experimental treatments after the assay sensitivity has been established. The advantage of the proposed test procedures is the additional ability to identify superior treatments while retaining an non-inferiority testing power comparable to that of existing testing procedures. Single-step and stepwise procedures are derived and then compared with each other to determine their relative testing power and testing error in a simulation study. Finally, the suggested procedures are illustrated with two clinical examples.

Discipline

Econometrics

Research Areas

Econometrics

Publication

Statistical Methods in Medical Research

ISSN

0962-2802

Identifier

10.1177/0962280216668913

Publisher

SAGE Publications (UK and US)

Additional URL

http://doi.org./10.1177/0962280216668913

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