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

Critical aspects of the Bayesian approach to phase I cancer trials.

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Novartis Pharma AG, Lichstrasse 35, 4056 Basel, Switzerland.


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.

[Indexed for MEDLINE]

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