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Wiley InterScience | ||||
  International Journal of Gynecological CancerVolume 13 Issue 3, Pages 251 - 261 Published Online: 13 Jun 2003 Journal compilation © 2008, IGCS and ESGO The official journal of the European Society of Gynecological Oncology
Abstract | References | Full Text: HTML, PDF (Size: 138K) | Related Articles | Citation Tracking  SPECIAL COLUMN Practical model-based dose-finding in phase I clinical trials: Methods based on toxicity Copyright IGCS, 2003 KEYWORDS adaptive decision making • Bayesian inference • clinical trial • dose‐finding • phase I • safety monitoring • toxicity Thall PF, Lee S-J. Practical model-based dose‐finding in phase I clinical trials: Methods based on toxicity. ABSTRACTWe describe two practical, outcome-adaptive statistical methods for dose‐finding in phase I clinical trials. One is the continual reassessment method and the other is based on a logistic regression model. Both methods use Bayesian probability models as a basis for learning from the accruing data during the trial, choosing doses for successive patient cohorts, and selecting a maximum tolerable dose (MTD). These methods are illustrated and compared to the conventional 3+3 algorithm by application to a particular trial in renal cell carcinoma. We also compare their average behavior by computer simulation under each of several hypothetical dose-toxicity curves. The comparisons show that the Bayesian methods are much more reliable than the conventional algorithm for selecting an MTD, and that they have a low risk of treating patients at unacceptably toxic doses. Accepted for publication March 3, 2003. | 
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