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Activity Number:
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145
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Type:
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Contributed
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Date/Time:
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Monday, July 30, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #309690 |
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Title:
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A Testing Strategy for Noninferiority and/or Superiority Hypotheses on Multiple Endpoints
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Author(s):
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Xiaohui Luo*+ and Jianjun Li
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Companies:
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Merck & Co., Inc. and Merck & Co., Inc.
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Address:
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181 Buttonwood Dr, Piscataway, NJ, 08854,
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Keywords:
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Multiple comparison ; Type I error ; Power ; Dose Range Finding ; Active control ; Non-inferior
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Abstract:
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In clinical trials comparing a study medication with an active control on multiple endpoints, it is not always the case that we need to show superiority of the study medication to the active control on all tested endpoints. Instead, the trial can be claimed positive if we can show that compared with the active control, the study medication is non-inferior on all endpoints, and superior on at least one of the endpoints. For example, the study medication is non-inferior on one efficacy endpoint and superior on the safety endpoint. We propose several approaches to test this composite hypothesis on multiple endpoints. Based on the comparison of our proposed approaches and the methods in the literature, the optimal testing strategy will be recommended and the formula for power calculation will be developed. The strategy will also be developed for dose range finding studies.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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