4 papers
TITE-STEIN: Time-to-event Simple Toxicity and Efficacy Interval Design to Accelerate Phase I/II Trials
Hao Sun, Jieqi Tu, Revathi Ananthakrishnan +1
Oncology dose-finding trials are shifting from identifying the maximum tolerated dose (MTD) to determining the optimal biological dose (OBD), driven by the need for efficient metho…
A Comparative Evaluation of Bayesian Model-Assisted Two-Stage Designs for Phase I/II Clinical Trials
Hao Sun, Jerry Li
The primary goal of a two-stage Phase I/II trial is to identify the optimal dose for the following large-scale Phase III trial. Recently, Phase I dose-finding designs have shifted…
Constructing optimal treatment length strategies to maximize quality-adjusted lifetimes
Hao Sun, Ashkan Ertefaie, Luke Duttweiler +1
Real-world clinical decision making is a complex process that involves balancing the risks and benefits of treatments. Quality-adjusted lifetime is a composite outcome that combine…
Statistical Operating Characteristics of Current Early Phase Dose Finding Designs with Toxicity and Efficacy in Oncology
Hao Sun, Hsin-Yu Lin, Jieqi Tu +2
Traditional phase I dose finding cancer clinical trial designs aim to determine the maximum tolerated dose (MTD) of the investigational cytotoxic agent based on a single toxicity o…