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Activity Number: 429
Type: Contributed
Date/Time: Wednesday, August 5, 2009 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #303823
Title: Use and Abuse of Statistics in Design and Analysis of Active Control Trials
Author(s): Kallappa M. Koti*+
Companies: FDA
Address: 10903 New Hampshire Avenue, Silver Spring, MD, 20993,
Keywords: Relative risk ; hazard ratio ; delta method ; confidence interval method ; synthesis method ; type 1 error rate
Abstract:

There is an acknowledged need for non-inferiority trials. Design and analysis of non-inferiority trials pose a challenge to statisticians. Consequently, much is published on current practices and problems in non-inferiority design and analysis. However, all that glitters is not gold. We review a number of published articles and point out what is technically right and what is not. We identify some, if not all, theoretically deficient steps used and unjustified claims made in some of these publications. We focus on non-inferiority margin determination and active-control effect preservation issues. We conclude that some of the objectives and the companion statistical problem formulations that are floated in these papers are mathematically intractable and/or impractical.

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