2 papers
stat.ME2025
BE-BOIN: A Dose Optimization Design Accommodating Backfill and Late-Onset Toxicity
Kai Chen, Yixuan Zhao, Kentaro Takeda +1
The US Food and Drug Administration (FDA) launched Project Optimus and issued guidance to reform dose-finding and selection trials, shifting the paradigm from identifying the maxim…
stat.ME2024
BOP2-TE: Bayesian Optimal Phase 2 Design for Jointly Monitoring Efficacy and Toxicity with Application to Dose Optimization
Kai Chen, Heng Zhou, J. Jack Lee +1
We propose a Bayesian optimal phase 2 design for jointly monitoring efficacy and toxicity, referred to as BOP2-TE, to improve the operating characteristics of the BOP2 design propo…