On the use of nonparametric curves in phase I trials with low toxicity tolerance

Biometrics. 2002 Mar;58(1):237-40. doi: 10.1111/j.0006-341x.2002.00237.x.


Gasparini and Eisele (2000, Biometrics 56, 609-615) propose a design for phase I clinical trials during which dose allocation is governed by a Bayesian nonparametric estimate of the dose-response curve. The authors also suggest an elicitation algorithm to establish vague priors. However, in situations where a low percentile is targeted, priors thus obtained can lead to undesirable rigidity given certain trial outcomes that can occur with a nonnegligible probability. Interestingly, improvement can be achieved by prescribing slightly more informative priors. Some guidelines for prior elicitation are established using a connection between this curve-free method and the continual reassessment method.

Publication types

  • Comment

MeSH terms

  • Bayes Theorem
  • Clinical Trials, Phase I as Topic*
  • Data Interpretation, Statistical
  • Dose-Response Relationship, Drug*
  • Humans
  • Maximum Tolerated Dose*
  • Statistics as Topic / methods*