Dose Optimization and Bayesian Methodologies in Clinical Trials: From Statistical Innovation to Regulatory Impact

Speaker: Dr. Ying Yuan

University of Texas MD Anderson Cancer Center

Ying Yuan is the Bettyann Asche Murray Distinguished Professor and Chair of the Department of Biostatistics at the University of Texas MD Anderson Cancer Center. Dr. Yuan is internationally renowned for his pioneering research in innovative Bayesian adaptive designs, including early-phase trials, seamless trials, biomarker-guided trials, hybrid control trials, Bayesian borrowing of historical data, and surrogate endpoints. The designs and software developed by Dr. Yuan’s lab (www.trialdesign.org) have been widely adopted by medical research institutes and pharmaceutical companies. Among these, the BOIN design, developed by Dr. Yuan’s team, is a groundbreaking oncology dose-finding method recognized by the FDA as a fit-for-purpose drug development tool. The BOP2 design is also widely used for efficacy and toxicity monitoring in early phase trials. Dr. Yuan is a member of the FDA Advisory Committee for Genetic Metabolic Diseases, an elected Fellow of the American Statistical Association, and the lead author of two books: Bayesian Designs for Phase I-II Clinical Trials and Model-Assisted Bayesian Designs for Dose Finding and Optimization, both published by Chapman & Hall/CRC.

Abstract:

TBD