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
BARD: A seamless two-stage dose optimization design integrating backfill and adaptive randomization
Yixuan Zhao, Rachael Liu, Jianchang Lin +1
One common approach for dose optimization is a two-stage design, which initially conducts dose escalation to identify the maximum tolerated dose (MTD), followed by a randomization…