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Superiority inferences on individual endpoints following noninferiority testing in clinical trials. Biom J 2008 Oct;50(5):693-703 PMID: 18932132

Pubmed ID

18932132

DOI

10.1002/bimj.200710447

Abstract

We consider the problem of drawing superiority inferences on individual endpoints following non-inferiority testing. Röhmel et al. (2006) pointed out this as an important problem which had not been addressed by the previous procedures that only tested for global superiority. Röhmel et al. objected to incorporating the non-inferiority tests in the assessment of the global superiority test by exploiting the relationship between the two, since the results of the latter test then depend on the non-inferiority margins specified for the former test. We argue that this is justified, besides the fact that it enhances the power of the global superiority test. We provide a closed testing formulation which generalizes the three-step procedure proposed by Röhmel et al. for two endpoints. For the global superiority test, Röhmel et al. suggest using the Läuter (1996) test which is modified to make it monotone. The resulting test not only is complicated to use, but the modification does not readily extend to more than two endpoints, and it is less powerful in general than several of its competitors. This is verified in a simulation study. Instead, we suggest applying the one-sided likelihood ratio test used by Perlman and Wu (2004) or the union-intersection t(max) test used by Tamhane and Logan (2004).

Author List

Logan BR, Tamhane AC

Author

Brent R. Logan PhD Director, Professor in the Institute for Health and Equity department at Medical College of Wisconsin




Scopus

2-s2.0-54549125945   12 Citations

MESH terms used to index this publication - Major topics in bold

Biometry
Clinical Trials as Topic
Endpoint Determination
Humans
Likelihood Functions
Models, Statistical
jenkins-FCD Prod-331 a335b1a6d1e9c32173c9534e6f6ff51494143916