JSM 2011 Online Program

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Abstract Details

Activity Number: 139
Type: Contributed
Date/Time: Monday, August 1, 2011 : 8:30 AM to 10:20 AM
Sponsor: Section on Statistics in Epidemiology
Abstract - #303321
Title: Type I Error Rate of Noninferiority Trials for a Dichotomous Outcome and Historical Comparator Group
Author(s): Caleb Andrew Bliss*+ and Joseph Massaro
Companies: Boston University and Boston University
Address: 801 Massachusetts Avenue, 3rd Floor, Boston, MA, 02118,
Keywords: Non-inferiority ; Type I Error Rate ; Historical Controls
Abstract:

Non-inferiority trials are commonly used to evaluate whether experimental treatments, compared to active controls, yield effects not worse than a pre-specified margin. Usually subjects are randomized to both treatment groups and methods for hypothesis evaluation are well defined. In some cases a historical control of data collected from a previously conducted trial is used for comparison. For a dichotomous outcome a natural hypothesis test is a two-sample test evaluating the null hypothesis of inferiority. While this is an application of the normal approximation for a binomial outcome under the null hypothesis of a non-zero risk difference, the properties of the hypothesis test have not been examined when applied with a historical comparator group. In this study we simulated data with a dichotomous outcome, a historical comparator, and a single experimental treatment group. We evaluated the type I error rate of the two-sample hypothesis test across a range of effect sizes and margins. The type I error rate was deflated. We examine alternatives to correct the test size.


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