2 citations · 2 across the 3 of their papers we have counts for
3 papers
stat.ME2024
A Seamless Phase II/III Design with Dose Optimization for Oncology Drug Development
Yuhan Li, Yiding Zhang, Gu Mi +1
The US FDA's Project Optimus initiative that emphasizes dose optimization prior to marketing approval represents a pivotal shift in oncology drug development. It has a ripple effec…
stat.AP2023★ 2 cited
A Multi-Arm Two-Stage (MATS) Design for Proof-of-Concept and Dose Optimization in Early-Phase Oncology Trials
Zhenghao Jiang, Gu Mi, Ji Lin +2
The Project Optimus initiative by the FDA's Oncology Center of Excellence is widely viewed as a groundbreaking effort to change the of conventional dose-findi…
stat.AP2023
Integration of Efficacy Biomarkers Together with Toxicity Endpoints in Immune-Oncology Dose Finding Studies
Yiding Zhang, Zhixing Xu, Hui Quan +1
The primary objective of phase I oncology studies is to establish the safety profile of a new treatment and determine the maximum tolerated dose (MTD). This is motivated by the dev…