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Activity Number: 245
Type: Contributed
Date/Time: Monday, July 30, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #306068
Title: Inferiority Index and the Behrens-Fisher Problem for Noninferiority Trials
Author(s): George Y.H. Chi*+
Companies: Janssen Pharmaceuticals R&D
Address: 12436 Over Ridge Rd, Potomac, MD, 20854, United States
Keywords: Inferiority index ; Non-inferiority trials ; Heterogeneity of variances ; Margin function ; Behrens-Fisher problem ; Welch's approximate t-test
Abstract:

The classical Behrens-Fisher problem poses the question regarding the form of the distribution of the test statistics under normality for the relative difference measure assuming heterogeneity of variances under the null hypothesis of a superiority trial. The so-called Behrens-Fisher distribution for the test statistic defined as the observed mean difference divided by the square root of the sum of the sample variances has been derived [Kim and Cohen (1998)]. Welch (1938) proposed an approximate t-test and derived its distribution. Dannenberg et al (1994) derived the corresponding extended Behrens-Fisher distribution for the test statistic under heterogeneity of variances for the equivalence hypothesis with a pre-specified equivalence margin for bioequivalence trials. In this paper, we will show how to apply the theory of inferiority index to derive an extended Behrens-Fisher distrib


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