Bridging across patient subgroups in phase I oncology trials that incorporate animal data.

ABSTRACT: In this paper, we develop a general Bayesian hierarchical model for bridging across patient subgroups in phase I oncology trials, for which preliminary information about the dose-toxicity relationship can be drawn from animal studies. Parameters that re-scale the doses to adjust for intrinsic differences in toxicity, either between animals and humans or between human subgroups, are introduced to each dose-toxicity model. Appropriate priors are specified for these scaling parameters, which capture the magnitude of uncertainty surrounding the animal-to-human translation and bridging assumption. After mapping data onto a common, 'average' human dosing scale, human dose-toxicity parameters are assumed to be exchangeable either with the standardised, animal study-specific parameters, or between

SUBMITTER: Zheng H 

PROVIDER: S-EPMC8129464 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature