Bayesian hierarchical model for dose-finding trial incorporating historical data

Feng Yu*, Qiqi Deng, Zhangyi He, Frank Fleischer, Linxi Han

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

Abstract

The Multiple Comparison Procedure and Modelling (MCPMod) approach has been shown to be a powerful statistical technique that can significantly improve the design and anal- ysis of dose-finding studies under model uncertainty. Due to its frequentist nature, how- ever, it is difficult to incorporate information into MCPMod from historical trials on the same drug. BMCPMod (Fleischer et al., 2022), a recently introduced Bayesian version of MCPMod, is designed to take into account historical information on the placebo dose group. We introduce a Bayesian hierarchical framework capable of incorporating histori- cal information on an arbitrary number of dose groups, including both placebo and active ones, taking into account the relationship between responses of these dose groups. Our approach can also model both prognostic and predictive between-trial heterogeneity and is particularly useful in situations where the effect sizes of two trials are different. Our goal is to reduce the necessary sample size in the dose-finding trial while maintaining its target power.
Original languageEnglish
JournalJournal of Biopharmaceutical Statistics
Early online date7 Sept 2023
DOIs
Publication statusE-pub ahead of print - 7 Sept 2023

Bibliographical note

Publisher Copyright:
© 2023 The Author(s). Published with license by Taylor & Francis Group, LLC.

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