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Efficient Dose Optimization through Backfill and Randomization

We are pleased to announce an exciting upcoming seminar as part of the ISBS Webinar Series on clinical trial innovation. The seminar, titled "Efficient Dose Optimization through Backfill and Randomization," will be held on January 17 2025, 11-12pm EST, featuring distinguished speakers Prof. Ying Yuan from the MD Anderson Cancer Center. Abstract: FDA’s Project Optimus raises the bar for dose-finding and optimization. The core requirement of this initiative is to gather more safety and efficacy data across multiple doses to identify the dose that achieves the optimal risk-benefit balance. In this talk, I will review backfill as a flexible and powerful approach to meet this goal without prolonging the timeline of drug development. I will discuss the implications and practical considerations of backfilling, such as when a dose should be opened or closed for backfilling and how to incorporate backfill data to adjust dose escalation, ensuring patient safety. Additionally, I will explore how to combine backfill with randomization to better inform optimal dose selection.