Critical aspects of the Bayesian approach to phase I cancer trials.
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.
Neuenschwander
Beat
B
Novartis Pharma AG, Lichstrasse 35, 4056 Basel, Switzerland. beat.neuenschwander@novartis.com
Branson
Michael
M
Gsponer
Thomas
T
D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001499:Bayes Theorem; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D003198:Computer Simulation; D006801:Humans; D015233:Models, Statistical; D009369:Neoplasms / Q000188:drug therapy*
D000970:Antineoplastic Agents