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Activity Number:
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151
- Enrichment Clinical Trials: Novel Designs, Statistical Inferences, and Case Studies
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 31, 2017 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #323019
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View Presentation
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Title:
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Estimators and Confidence Intervals for Adaptive Two-Stage Designs for Population Enrichment
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Author(s):
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Vladimir Dragalin* and Ionut Bebu
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Companies:
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Janssen R&D and The George Washington University
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Keywords:
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Adaptive design ;
Population enrichment ;
estimator ;
confidence interval ;
two-stage design ;
personalized medicine
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Abstract:
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A conditional likelihood-based approach is proposed to construct confidence intervals for the parameters of interest in a two-stage design with the option of population enrichment after the first stage. Both a Wald confidence interval and a confidence interval based on inverting the likelihood ratio test are proposed. The operating characteristics of these confidence intervals: the coverage probabilities and average confidence interval lengths, as well as the average bias and mean-square error of the corresponding point estimates, compare favorably with other available techniques. Although conceptually simple, the new methods have a much wider scope than the methods currently available.
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Authors who are presenting talks have a * after their name.
