Incorporating Individual and Collective Ethics into Phase I Cancer Trial Designs

TL;DR

This paper introduces a Bayesian Phase I cancer trial design that integrates individual and collective ethical considerations, improving dose estimation accuracy and safety over existing methods.

Contribution

A novel Bayesian framework that incorporates both individual and collective ethics into Phase I cancer trial designs, enhancing safety and accuracy.

Findings

Outperforms existing Bayesian designs in dose estimation accuracy.

Reduces toxicity and overdose rates compared to traditional methods.

Effectively balances individual patient safety with collective ethical considerations.

Abstract

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