The Effective Statistician - in association with PSI Early Development and The Dose Selection in the Immune-oncology
Dec 16, 2024
Teppo Huttunen, a Finnish statistician and founder of Eskimage, delves into the complexities of dose selection in immune-oncology. He discusses the challenges of traditional 3+3 design and advocates for the more flexible BOIN design. Teppo emphasizes the balance between safety and efficacy, exploring the crucial role statisticians play in oncology research. He also highlights the importance of industry trends, FDA guidance, and practical challenges in optimizing dose design, making this conversation essential for anyone interested in advancing oncology treatment.
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Oncology Dose Selection Advice
- In oncology dose selection, consider limitations of 3+3 designs.
- Explore alternative approaches for optimal dosing.
3+3 Design Limitations
- The 3+3 design effectively identifies maximum tolerated doses (MTD) for cytotoxic agents.
- It assumes MTD is most effective, unsuitable for immuno-oncology.
Optimal Biological Dose
- In immuno-oncology, maximum tolerated dose isn't always the most effective.
- Consider the optimal biological dose, balancing safety and efficacy.