Journal
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
Volume 24, Issue 1, Pages 94-109Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/10543406.2013.856025
Keywords
Decision making; Influence condition; Interaction condition; Subgroup analysis; Tailored therapeutics
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Multipopulation tailoring trials provide a trial design option that supports the realization of tailored therapeutics or personalized medicine. Several recent publications have focused on statistical and clinical considerations that arise in these trials that are designed to study the overall treatment effect in a population of interest as well as one or more prospectively defined subpopulations. Millen et al. (2012) introduced the influence and interaction conditions as part of a general framework to facilitate decision making in multipopulation trials. This article provides Bayesian methods for assessing the influence and interaction conditions. The methods introduced are illustrated using case studies based on clinical trials with biomarker-driven designs.
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