Critical aspects of the Bayesian approach to phase I cancer trials

Abstract

The Bayesian approach to finding the maximum‐tolerated dose in phase I cancer trials is discussed. The suggested approach relies on a realistic dose–toxicity model, allows one to include prior information, and supports clinical decision making by presenting within‐trial information in a transparent way. The modeling and decision‐making components are flexible enough to be extendable to more complex settings. Critical aspects are emphasized and a comparison with the continual reassessment method (CRM) is performed with data from an actual trial and a simulation study. The comparison revealed similar operating characteristics while avoiding some of the difficulties encountered in the actual trial when applying the CRM. Copyright © 2008 John Wiley & Sons, Ltd.