BIOS-05. BACKFILL: A FLEXIBLE AND POWERFUL APPROACH FOR DOSE OPTIMIZATION

Abstract Backfill is a key approach emphasized in the FDA’s guidance on dose optimization. In this presentation, I will explore the critical and versatile role of backfill in dose optimization, focusing on its statistical and design considerations. Specifically, I will address criteria for opening and closing backfill cohorts and strategies for integrating backfill data to enhance the safety and reliability of dose escalation. Additionally, I will discuss incorporating backfill into multi-dose optimization, as well as its application in single-agent trials, combination trials, and trials with late-onset toxicity. Finally, I will highlight practical considerations for implementing backfill effectively.