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 - #307048 |
Title:
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Testing a Primary and a Secondary Endpoint in a Group Sequential Design
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Author(s):
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Ajit C. Tamhane*+ and Cyrus R. Mehta and Lingyun Liu
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Companies:
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Northwestern University and Cytel Inc. and Cytel Inc.
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Address:
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Department of IEMS, Evanston, IL, 60208,
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Keywords:
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Gatekeeping procedures ;
Multiple endpoints ;
O'Brien-Fleming boundary ;
Pocock boundary ;
Primary power ;
Secondary power
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Abstract:
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We consider a clinical trial where the primary endpoint is a gatekeeper for the secondary endpoint. A two-stage group sequential test is used. The FWER of false significance on either endpoint is to be controlled at level a. The type I error rate for the primary endpoint is controlled by choosing any a-level boundary, e.g., the O'Brien-Fleming (OF) or the Pocock (PO) boundary. Given any a-level boundary for the primary endpoint, the boundary for the secondary endpoint to control the FWER is determined. We show that the FWER is maximized when the correlation coefficient ? between the two endpoints equals 1. The critical constants required to control the FWER are computed for different combinations of OF and PO boundaries and for different ?. When ? is unknown, the upper confidence limit on ? from the first stage data is used to compute boundaries. A clinical trial example is provided.
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