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Abstract Details
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Activity Number:
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572
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Type:
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Contributed
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Date/Time:
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Wednesday, August 3, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Section on Health Policy Statistics
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| Abstract - #301894 |
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Title:
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Unknown Correlation Coefficient Between a Primary and a Secondary Endpoint in a Two-Stage Group Sequential Design
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Author(s):
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Yi Wu*+ and Ajit C. Tamhane and Cyrus Mehta
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Companies:
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Northwestern University and Northwestern University and Cytel Inc.
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Address:
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Dept of Statistics, Evanston, IL, 60208,
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Keywords:
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group sequential design ;
clinical trials ;
multiple endpoints ;
correlation coefficient ;
familywise error rate
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Abstract:
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We consider a two-stage group sequential design with a primary and a secondary endpoint where the secondary endpoint is tested only if the primary endpoint shows significance. We assume that the two endpoints follow a bivariate normal distribution with unknown correlation coefficient \rho. Setting \rho=1 will provide the most conservative critical boundary (Tamhane, Mehta and Liu 2010). However, replacing \rho with its sample estimate r will cause familywise error rate (FWER) inflation when r is less than \rho. We have developed an approach to control the overall FWER with adjusted second stage critical boundary utilizing the upper confidence limit of \rho. The power gain for rejecting the secondary hypothesis of the new approach over the conservative method is discussed.
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