Bayesian decision procedures based on logistic regression models for dose-finding studies

Abstract

Early-phase clinical trials, conducted to determine the appropriate dose of an experimental drug to take forward to later trials, are considered. The objective is to find the dose associated with some low probability of an adverse event. A Bayesian model is presented, and a decision-theoretic procedure for finding the optimal doses for each of a series of cohorts of subjects is derived. The procedure is flexible and can easily be conducted using standard statistical software. The results of simulations investigating the properties of the procedure are presented.