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MUCE: Bayesian Hierarchical Modeling for the Design and Analysis of Phase 1b Multiple Expansion Cohort Trials

Jiaying Lyu, Tianjian Zhou, Shijie Yuan, Wentian Guo, Yuan Ji

arXiv, 2020

Abstract

We propose a multiple cohort expansion (MUCE) approach as a design or analysis method for phase 1b multiple expansion cohort trials, which are novel first-in-human studies conducted following phase 1a dose escalation. The MUCE design is based on a class of Bayesian hierarchical models that adaptively borrow information across arms. Statistical inference is directly based on the posterior probability of each arm being efficacious, facilitating the decision making that decides which arm to select for further testing.

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