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Activity Number:
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528
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Type:
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Contributed
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Date/Time:
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Wednesday, August 5, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304451 |
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Title:
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Power and Multiplicity Assessment for a Composite Endpoint and Its Components in Multi-Regional Clinical Trials
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Author(s):
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Hongwei Wang and Weili He and Liang Chen*+
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Companies:
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Merck & Co., Inc. and Merck & Co., Inc. and Merck & Co., Inc.
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Address:
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, Rahway, NJ, 07065,
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Keywords:
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composite endpoint ; components ; multi-regional study ; multiplicity adjustment ; power
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Abstract:
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A composite endpoint may provide a more comprehensive assessment of clinical response than a single outcome, and is often thought as a means to increase the ability of a study to discern a drug effect. However, this may not be true even if the treatment effect of each component trends in the same direction. Further, different regulatory agencies may have significantly different requirements for the drug development in a specific therapeutic area, which could take the form of a composite or its components as primary endpoints. This raises the issue of multiplicity in multi-regional studies. To this end, theoretical evaluation and simulation studies were conducted regarding power performance of a composite versus its components along with competing multiplicity adjustment strategies. Some practical recommendations will be given based on such evaluation.
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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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