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Analysis explores dose optimization using backfill, indicating improved reliability and safety measures.
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.
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Ying Yuan (2025) studied this question.
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