The continual reassessment method in cancer phase I clinical trials: a simulation study

Stat Med. 1993 Jun 30;12(12):1093-108. doi: 10.1002/sim.4780121201.


In cancer studies, the aim of phase I clinical trials is to identify an appropriate dose for experimentation in phase II and III studies. The continual reassessment method (CRM) has been developed recently and presented as the method of choice in the design and analysis of such phase I studies. However, to implement the method, some methodological and practical considerations must be addressed. This paper examines, through a simulation study, the sensitivity of CRM both to the initial modelling of the dose-toxicity relationship and the prior. It appears that the performance of CRM can be improved by using vague priors and initial tuning of the model to allow flexibility.

Publication types

  • Comparative Study

MeSH terms

  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / toxicity
  • Bayes Theorem
  • Bias
  • Clinical Trials, Phase I as Topic* / methods
  • Clinical Trials, Phase I as Topic* / standards
  • Dose-Response Relationship, Drug
  • Ethics, Medical
  • Evaluation Studies as Topic
  • Humans
  • Logistic Models
  • Models, Statistical*
  • Monte Carlo Method
  • Neoplasms / drug therapy*
  • Neoplasms / epidemiology
  • Organizational Objectives
  • Research Design*
  • Sensitivity and Specificity


  • Antineoplastic Agents