Critical aspects of the Bayesian approach to phase I cancer trials

Stat Med. 2008 Jun 15;27(13):2420-39. doi: 10.1002/sim.3230.


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.

Publication types

  • Comparative Study

MeSH terms

  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects*
  • Bayes Theorem*
  • Clinical Trials, Phase I as Topic / methods*
  • Computer Simulation
  • Humans
  • Models, Statistical*
  • Neoplasms / drug therapy*


  • Antineoplastic Agents