Publication Type
Journal Article
Version
publishedVersion
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.
Keywords
Non-inferiority, superiority, three-arm trial, familywise error rate, assay sensitivity
Discipline
Econometrics
Research Areas
Econometrics
Publication
Statistical Methods in Medical Research
Volume
27
Issue
6
First Page
1751
Last Page
1765
ISSN
0962-2802
Identifier
10.1177/0962280216668913
Publisher
SAGE
Citation
ZHONG, JunJiang; KWONG, Koon Shing; and CHEUNG, Siu Hung.
Testing of non-inferiority and superiority for three-arm clinincal studies with multiple experimental treatments. (2016). Statistical Methods in Medical Research. 27, (6), 1751-1765.
Available at: https://ink.library.smu.edu.sg/soe_research/1933
Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-No Derivative Works 4.0 International License.
Additional URL
https://doi.org./10.1177/0962280216668913
