JSM 2005 - Toronto

Abstract #303551

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Activity Number: 200
Type: Contributed
Date/Time: Monday, August 8, 2005 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #303551
Title: Noninferiority Hypothesis with Binary Endpoints
Author(s): Tie-Hua Ng*+
Companies: U.S. Food and Drug Administration
Address: 1401 Rockville Pike, #200S, HFM-219, Rockville, MD, 20852-1448, United States
Keywords: Active control ; noninferiority margin ; binary ; odds ratio
Abstract:

The noninferiority (NI) margin should be a small fraction of the therapeutic effect of the active control as compared to placebo. Such a proposal works well in testing the NI hypothesis of the mean difference with a continuous outcome rather than a binary endpoint. For testing the NI hypothesis of the mean ratio, I propose a similar NI margin on a log scale. This proposal also works well in testing the NI hypothesis for survival data based on hazard ratio. I will discuss pitfalls of testing the NI hypothesis with binary endpoints based on the difference or the ratio of proportions and testing the NI hypothesis with binary endpoints based on odds ratio.

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Revised March 2005