Volume 27, Issue 13
Research Article

Critical aspects of the Bayesian approach to phase I cancer trials

Beat Neuenschwander

Corresponding Author

E-mail address: beat.neuenschwander@novartis.com

Novartis Pharma AG, Lichstrasse 35, 4056 Basel, Switzerland

Novartis Pharma AG, Lichstrasse 35, 4056 Basel, SwitzerlandSearch for more papers by this author
Michael Branson

Novartis Pharma AG, Lichstrasse 35, 4056 Basel, Switzerland

Search for more papers by this author
Thomas Gsponer

Novartis Pharma AG, Lichstrasse 35, 4056 Basel, Switzerland

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First published: 14 March 2008
Citations: 132

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. Copyright © 2008 John Wiley & Sons, Ltd.

Number of times cited according to CrossRef: 132

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