The Oncology Center of Excellence initiative, Project Optimusa, and its related FDA Draft Guidance emphasize the shift from finding the maximum tolerated dose to the biologically optimal dose for non-cytotoxic oncology therapeutic products. This approach requires more data, and oncology drug developers must focus on meeting expectations for dose optimization before achieving drug approval.
Randomization to different doses is key and allows for dose optimization in a registrational Phase 2/3 trial, potentially with the aim of accelerated approval. IDDI invites you to join an exceptional Lunch and Learn on dose optimization, accelerated approval, and adaptive designs:

This lunch and learn session will provide:

• An overview of important aspects of Project Optimus and accelerated approval with a focus on statistical methods and adaptive trials, including model‑based and model-assisted dose escalation designs, adaptive designs for dropping a dose arm at interim
• Phase 2/3 trials testing both an early and late endpoint for accelerated and full approval
• The role of group sequential designs and sample size reassessment when designing registrational trials without good information on treatment effectiveness