Patient-specific dose finding in seamless phase I/II clinical trials

Abstract

This article incorporates a covariate to determine the optimum dose in a seamless phase I/II clinical trial. A binary covariate and its interaction effect are assumed to keep the method simple. Each patient’s outcome is assumed to be trinomial, and the continuation ratio model is utilized to model the dose–response data. The Bayesian approach estimates parameters of the dose–response model. Eight plausible dose–response scenarios are investigated to check the proposed methodology. A simulation study shows that covariate consideration can enhance the identification of the optimum dose when it is appropriate to do.

KEYWORDS:

• Dose-finding study
• dose–response model
• optimum dose
• patients’ heterogeneity
• seamless phase I/II trial

SUBJECT CLASSIFICATIONS:

• 62P10
• 62K99
• 62L05

ACKNOWLEDGMENTS

The authors thank the Editors and anonymous reviewers for their valuable comments that have improved the article. The authors would like to deeply thank the University of Dhaka, Bangladesh, for their generous financial support to this study through the Centennial Research Grant.

DISCLOSURE

The authors have no conflicts of interest to report.