Abstract #300696

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JSM 2003 Abstract #300696
Activity Number: 130
Type: Contributed
Date/Time: Monday, August 4, 2003 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #300696
Title: Monitoring Noninferiority Trials for Inferiority
Author(s): Yulan Li*+
Companies: Novartis Pharmaceuticals
Address: Building 419, East Hanover, NJ, 07936,
Keywords: noninferiority ; noninferiority margin ; futility ; interim monitoring
Abstract:

For a noninferiority trial comparing a new therapy with standard therapy in patients with a life threatening disease, it is ethically imperative to stop the trial early if the new therapy turns out to be worse than the standard therapy. However, existing approaches developed for superiority trials are not applicable as the futility criteria are based on the new therapy being not better than the standard therapy by a positive margin. For noninferiority trials, we want to terminate the trial early if the new therapy is worse than the standard therapy by the (negative) noninferiority margin. The futility criteria are a-levels at which the probability of detecting if the new therapy is worse than the standard therapy by the (negative) noninferiority margin is controlled at 95%. These futility levels are guidelines for terminating the trial. We discuss the timing of the interim monitoring and the choice of futility levels.

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