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Activity Number:
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315
- Statistical Innovation in Biomarker-Guided Clinical Development
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Type:
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Invited
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Date/Time:
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Tuesday, August 9, 2022 : 2:00 PM to 3:50 PM
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Sponsor:
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General Methodology
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Abstract #320739
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Title:
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Bayesian Adaptive Alpha Allocation for Phase III Trials with Biomarker and Overall Population Objectives
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Author(s):
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Yue Shentu* and Cong Chen and Xuekui Zhang
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Companies:
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Daiichi Sankyo Inc. and Merck & Co., Inc. and University of Victoria
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Keywords:
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biomarker subgroup;
adaptive design;
Bayesian;
multiplicity
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Abstract:
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Phase III trials with dual hypotheses in both a biomarker subpopulation and the overall population is often seen in clinical development programs where the predictive strength and prevalence for the pre-determined biomarker is uncertain. Sponsors often want to be able to establish the drug's efficacy in the all-comer population but also have a chance to demonstrate the efficacy in the biomarker subpopulation in case if the benefit-risk assessment in the biomarker negative subpopulation is not favorable. Alpha allocation to the overall population and the biomarker subpopulation is often informed by limited phase I and II data, but further optimization based on the current trial is possible in an adaptive framework. We will investigate a stepwise Bayesian alpha allocation adaptation design with the goal to improve the probability of success for either a positive trial in the overall population or the biomarker subpopulation.
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Authors who are presenting talks have a * after their name.
