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