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Activity Number:
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323
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, July 31, 2007 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309307 |
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Title:
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Control of Type I Error and the Correlation of Multiple Endpoints in a Medical Device Trial
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Author(s):
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Kevin Najarian*+ and Carola Alfaro
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Companies:
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Boston Scientific Corporation and Boston Scientific Corporation
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Address:
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41 Howard Street, Milford, MA, 01757,
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Keywords:
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Medical Device ; Multiple Endpoints ; Type I Error Rate ; Multiplicity ; Correlation ; Homogeneity
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Abstract:
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Medical device clinical trials often consider multiple endpoints to assess the efficacy and safety of a given treatment. And while these clinical response endpoints may be classified as primary and secondary, the interpretation of the results must be considered carefully. Multiple univariate analyses can inflate the type I error rate, and therefore, some adjustments of the observed p-values for multiplicity of tests may be necessary. In addition to many common techniques for multiplicity adjustments, there are some that utilize correlation information and consider the homogeneity of treatment effects to determine the magnitude of the adjustments necessary. An analysis of real-life simulated medical device data is considered to assess techniques for multiplicity with added regard to the relationships among endpoints.
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