Ying Yuan PhD, Distinguished Professor and Deputy Chair in the Department of Biostatistics at the University of Texas will be giving a presentation on “BOIN Suite: a Bayesian Design Platform to Innovate Phase I Clinical Trials.” This presentation is entirely virtual, and will occur on August 13, 2024, 12:00pm - 1:00pm via Zoom. Registration is required, and upon registration, attendees will received a confirmation email with information about joining the meeting.

ABSTRACT: The US Food and Drug Administration (FDA) granted the Bayesian optimal interval (BOIN) design the fit-for-purpose designation as a tool for drug development. This is the third design that received this prestigious designation over the last decade. In this talk, I will review BOIN designs as an integrated platform to innovate phase I oncology trials. BOIN designs can be implemented in a simple way as the 3+3 design but deliver superior operating characteristics comparative to the state-of-the-art more complicated model-based Bayesian adaptive designs. BOIN designs are versatile and provide a unified framework to accommodate various types of phase I trials, including single-agent trials, drug-combination trials, trials with late-onset toxicity, and trials to find the optimal biological dose. Practical guidance and software, freely available at www.trialdesign.org, will be provided with real-world trial.