Chair: Victoria Chang, PhD (JBS | BeiGene)
Instructor: Ying Yuan, PhD (The University of Texas MD Anderson)
Course Description:
The FDA Oncology Center of Excellence launched Project Optimus with the goal of reforming the dose optimization and selection paradigm in oncology drug development. To facilitate this shift, the FDA also released draft guidance titled “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases”
Dose optimization trials are more complex than conventional MTD-finding trials, involving the benefit-risk assessment of the doses. As a result, it likely increases costs and prolongs the timeline for early phase drug development. Therefore, it is critically important to have efficient and novel statistical design strategies to address these challenges and meet the increasing regulatory requirements for oncology dose justification.
The aim of this short course is to elucidate statistical strategies and practical considerations related to the planning and execution of dose optimization trials. The course will cover a variety of phase I/II dose optimization designs and phase II/III dose optimization designs. We will provide real-world trial examples to illustrate key considerations, and software to enable participants to design their own dose-optimization trials after the completion of this short course.
Instructor:
Ying Yuan, PhD
Department of Biostatistics
The University of Texas MD Anderson
yyuan@mdanderson.org
Ying Yuan is Bettyann Asche Murray Distinguished Professor and Deputy Chair in the Department of Biostatistics at University of Texas MD Anderson Cancer Center. Dr. Yuan is an internationally renowned researcher in innovative Bayesian adaptive designs, with over 150 statistical methodology papers published on early phase trials, seamless trials, biomarker-guided trials, and basket and platform trials. The designs and software developed by Dr. Yuan’s lab (www.trialdesign.org) have been widely used in medical research institutes and pharmaceutical companies. The BOIN design, developed by Dr. Yuan’s team, is a groundbreaking oncology dose-finding design that has been recognized by the FDA as a fit-for-purpose drug development tool. Dr. Yuan was elected as the American Statistical Association Fellow, and is the leading 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.
