This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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226
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 2, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #307740 |
Title:
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Method of Balanced Adjustment in Testing Coprimary Endpoints
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Author(s):
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George Kordzakhia*+
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Companies:
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FDA
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Address:
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10903 New Hampshire Ave., building 21, Silver Spring, MD, 20993-0002, USA
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Keywords:
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co-primary endpoints ;
type I error rate
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Abstract:
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In a clinical trial with multiple co-primary endpoints, the type II error could increase depending on the correlation among the endpoints. Patel (1991) proposed an approach that adjusts the significance levels for testing each co-primary endpoint based on the idea of restricting the null space. In the scenario that statistical significance of each individual hypothesis is not required, we introduce a testing approach in which the significance level for a co-primary endpoint is adjusted upward only if the treatment shows high significance in one (or more than one) of the remaining co-primary endpoints. The method is applicable for the scenario where the null space is restricted. Our testing approach controls maximum joint false positive rate over the restricted null space, but it does not assure that each individual hypothesis is statistically significant.
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Authors who are presenting talks have a * after their name.
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