Patient-specific dose finding in phase I clinical trials

This article proposes an extension of the continual reassessment method to determine the maximum tolerated dose (MTD) in the presence of patients' heterogeneity in phase I clinical trials. To start with a simple case, we consider the covariate as a binary variable representing two groups of patients. A logistic regression model is used to establish the dose-response relationship and the design is based on the Bayesian framework. Simulation studies for six plausible dose-response scenarios show that the proposed design is likely to determine the MTD more accurately than the design that does not take covariate into consideration.