On the Relative Conservativeness of Bayesian Logistic Regression Method in Oncology Dose-Finding Studies

Authors

Cheng-Han Yang
Guanghui Cheng
Ruitao Lin

Publication Date

1-1-2024

Journal

Pharmaceutical Statistics

Abstract

The Bayesian logistic regression method (BLRM) is a widely adopted and flexible design for finding the maximum tolerated dose in oncology phase I studies. However, the BLRM design has been criticized in the literature for being overly conservative due to the use of the overdose control rule. Recently, a discussion paper titled "Improving the performance of Bayesian logistic regression model with overall control in oncology dose-finding studies" in Statistics in Medicine has proposed an overall control rule to address the "excessive conservativeness" of the standard BLRM design. In this short communication, we discuss the relative conservativeness of the standard BLRM design and also suggest a dose-switching rule to further enhance its performance.

Keywords

Bayes Theorem, Humans, Logistic Models, Maximum Tolerated Dose, Dose-Response Relationship, Drug, Clinical Trials, Phase I as Topic, Antineoplastic Agents, Neoplasms, Research Design, Bayesian logistic regression model, Dose finding, Maximum tolerated dose, Overdose control, Phase I trial

DOI

10.1002/pst.2364

PMID

38317370

PMCID

PMC11789473

PubMedCentral® Posted Date

2-3-2025

PubMedCentral® Full Text Version

Author MSS

Published Open-Access

yes