Early Development and The Dose Selection in the Immune-oncology

Key points:

• Dose Selection Challenge
• Limitations of 3+3 Design
• BOIN Design
• Backfilling
• Efficacy vs. Safety
• Statisticians’ Role
• Practical Challenges
• FDA Guidance
• Cross-Functional Approach
• Industry Trends
• Cost & Timeline Estimation

Understanding dose selection in immune-oncology is crucial for developing safer and more effective treatments, and statisticians play a central role in driving these decisions.

In this episode, Teppo shares practical insights into overcoming the limitations of traditional methods and adopting more flexible approaches like the BOIN design.

If you want to stay ahead in oncology research and learn how to balance safety, efficacy, and practical challenges in dose optimization, this episode is a must-listen!