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A general framework is proposed for Bayesian model-based designs of Phase Icancer trials, in which a general criterion for coherence (Cheung, 2005) of adesign is also developed. This framework can incorporate both "individual" and"collective" ethics into the design of the trial. We propose a new design whichminimizes a risk function composed of two terms, with one representing theindividual risk of the current dose and the other representing the collectiverisk. The performance of this design, which is measured in terms of theaccuracy of the estimated target dose at the end of the trial, the toxicity andoverdose rates, and certain loss functions reflecting the individual andcollective ethics, is studied and compared with existing Bayesian model-baseddesigns and is shown to have better performance than existing designs.

Incorporating Individual and Collective Ethics into Phase I Cancer Trial Designs