JSM 2005 Online Program

Abstract #303614

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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 - #303614
Title:	Improved Methods for Establishing Noninferiority in Clinical Trials
Author(s):	Farid Kianifard*+ and Michael Chen and Sunil K. Dhar
Companies:	Novartis Pharmaceuticals and Novartis Pharmaceuticals and New Jersey Institute of Technology
Address:	Biometrics, East Hanover, NJ, 07936, United States
Keywords:	Active-control ; Bootstrapping ; Equivalence
Abstract:	We consider a randomized, active-control clinical trial setting in which the objective is to test for noninferiority of the experimental treatment compared to control. An approach for defining a noninferiority margin is based on the concept of preserving a certain fraction of the active control effect. Noninferiority is established if the ratio of the lower limit of the two-sided 95% confidence interval for the treatment difference to the estimated mean of the active control is greater than a prespecified fraction. The nominal significance level, depending on values of location and scale parameters, may not be maintained by this confidence-interval approach to testing noninferiority. We examine bootstrap methods to derive a more accurate lower limit of the confidence interval for known functions of the treatment means. This, in turn, improves the power of the test, which we will demonstrate through simulation. We also will explore other methods of establishing noninferiority or equivalence.

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