A new design of the continual reassessment method

Abstract

We propose a new design of the continual reassessment method and systematically evaluate its performance on certain operating measures to satisfy the requirements of collective and individual ethics. Simulation results are derived to compare the new design with currently available designs on criteria BEARS: Benchmark, Efficiency, Accuracy, Reliability, Safety. Overall, the new design performs well and safely avoids toxic doses (hence safeguarding individual ethics) while reliably identifying the maximum tolerated dose (hence protecting collective ethics).

Keywords:

• Bayesian method
• Continual reassessment method
• Maximum tolerated dose
• Phase I clinical trial
• Toxicity

Acknowledgments

The authors thank the Associate Editor and an anonymous Referee for valuable comments and constructive suggestions that have helped improve the manuscript.

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

Xikui Wang and Po Yang are supported by the Natural Sciences and Engineering Research Council (NSERC) of Canada. Xikui Wang also acknowledges research funding from the University of Manitoba.