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Abstract Details
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Activity Number:
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501
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 3, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301541 |
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Title:
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Assessing Noninferiority in Multiregion Trial Using the Bayesian Approach
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Author(s):
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Satrajit Roychoudhury*+
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Companies:
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Novartis
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Address:
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180 PARK AVENUE, FLORHAM PARK, NJ, 07932, United States
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Keywords:
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multi-regional clinical trial ;
heterogeneity ;
Hierarchical bayesian model ;
Dirichlet process
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Abstract:
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In multi-regional clinical trials one of the key issue is how to assess the consistency of treatment effect across different regions. Recently most confirmatory trials recruit patients across the world. It is very important for regulatory authorities to ensure that the drug is effective overall. This information is also valuable for sponsors as it gives a good picture of disease and population characteristics in different regions which is valuable to plan future trials. In this article, we proposed a semiparametric bayesian methodology to assess the overall consistency of treatment effect across all regions in Phase III noninferiority trial. In particular a shared parameter model between the two endpoint are developed by assuming a semiparametric Dirichlet process prior for the shared parameter. The model will be assessed using simulation study and data analysis.
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Authors who are presenting talks have a * after their name.
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