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.