Critical aspects of the Bayesian approach to phase I cancer trials |
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Authors: | Neuenschwander Beat Branson Michael Gsponer Thomas |
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Affiliation: | Novartis Pharma AG, Lichstrasse 35, 4056 Basel, Switzerland. beat.neuenschwander@novartis.com |
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Abstract: | 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. |
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Keywords: | maximum‐tolerated dose continual reassessment method logistic model |
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