Bayesian hierarchical EMAX model for dose-response in early phase efficacy clinical trials.

ABSTRACT: A primary goal of a phase II dose-ranging trial is to identify a correct dose before moving forward to a phase III confirmatory trial. A correct dose is one that is actually better than control. A popular model in phase II is an independent model that puts no structure on the dose-response relationship. Unfortunately, the independent model does not efficiently use information from related doses. One very successful alternate model improves power using a pre-specified dose-response structure. Past research indicates that EMAX models are broadly successful and therefore attractive for designing dose-response trials. However, there may be instances of slight risk of nonmonotone trends that need to be addressed when planning a clinical trial design. We propose to add hierarchical parameters to

SUBMITTER: Gajewski BJ 

PROVIDER: S-EPMC6606375 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature