In this episode, the IDDI experts will explore the role of randomized trials for dose optimization.
Key takeaways:
- Role of randomized trials for dose optimization
- How dose optimization can potentially be integrated in seamless phase 2/3 trials
Speakers:
- Elisabeth Coart, Director, Statistical Consulting & Research
- Leandro Garcia Barrado, Senior Scientist, Statistical Research
- Moderator: Erik Falvey, Sr. Director Business Development Europe
About the Podcast Series:
In January 2023, the Food and Drug Administration (FDA) released a draft guidance detailing the core principles of Project Optimus. This initiative aims to educate, innovate, and collaborate with relevant stakeholders to advance a dose-finding and dose-optimization framework in oncology, ensuring an optimal balance between efficacy, safety, and tolerability of new therapies. In August 2024, the final guidance was published, incorporating feedback from various stakeholders.
The IDDI experts will dive into this initiative and its implications on oncology drug development through 5 episodes:
- Episode 1: From idea to final FDA guidance on dose optimization in oncology
- Episode 2: Dose-finding designs: establishing safety and tolerability of a dose
- Episode 3: Role of PK/PD in dose-finding and dose-optimization
- Episode 4: Designing randomized trials for dose optimization
- Episode 5: Generalized Pairwise Comparison (GPC) for dose finding
Stay tuned for this insightful podcast series and contact our experts for a complete guidance from dosing and study design to regulatory strategy and submission!
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