Activity Number:
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337
- Interim Monitoring and Analyses: Two-Stage, Multi-Stage, and Group Sequential Designs
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Type:
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Contributed
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Date/Time:
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Tuesday, August 1, 2017 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #324416
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Title:
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Strategies in Designing Interim Analyzes Under Discrete Random-Effects Model in a Multiregional Trial
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Author(s):
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Hsiao-Hui Tsou* and Chi-Tian Chen and K. K. Gordon Lan and Chin-Fu Hsiao
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Companies:
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National Health Research Institutes and National Health Research Institutes and Janssen Pharmaceutical Companies of Johnson & Johnson and National Health Research Institutes
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Keywords:
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multiregional clinical trial ;
interim analysis ;
Discrete Random-Effects Model ;
sample size allocation
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Abstract:
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When designing a trial, the sample size is usually estimated from limited information. It would be desirable to modify total sample size or adjust sample size allocation using accumulated data for increasing the efficiency of clinical trials. In this research, we focus on the design of a multiregional trial since developing pharmaceutical products via multiregional clinical trials has become a preferred strategy. We consider a discrete random effects model to account for heterogeneous treatment effect across regions. We propose some strategies for sample size re-estimation or sample size re-allocation to increase the efficiency of a clinical trial.
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Authors who are presenting talks have a * after their name.