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Activity Number:
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418
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Type:
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Contributed
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Date/Time:
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Wednesday, August 1, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309713 |
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Title:
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Multiplicity Adjustment for Testing of Multiple Endpoints in Group Sequential Study Design
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Author(s):
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Xiang Zhang+ and Jianming Wang*+ and Chunlei Ke
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Companies:
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Amgen Inc. and Amgen Inc. and Amgen Inc.
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Address:
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2811 Arguello Drive, Burlingame, CA, 94010, One Amgen Center Drive, Thousand Oaks, CA, 91320,
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Keywords:
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hierarchical testing ; Group sequential study design ; primary endpoint ; secondary endpoints ; type I error rate
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Abstract:
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Group sequential study design with multiple endpoints is very common in clinical trials, and the group sequential method is widely used in the primary efficacy endpoint in terms of controlling type I error rate. Not many papers have been published regarding how to control type I error rate using a group sequential rule based on multiple endpoints. In particular, when primary and secondary endpoints are tested hierarchically (secondary endpoints will be tested only if primary endpoint is tested significantly), it is not quite clear what is the optimal in controlling type I error rate in testing secondary endpoints. The purpose of our research is to evaluate performances of several common procedures in terms of controlling type I error rate strongly (experimental-wise error rate), and wish to shed some lights on how to make selection among several common procedures.
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