Listen to the second episode of our Podcast Series as our experts dive deep into one vs two trials approaches strategies for Accelerated Approvals.
Key Learning Objectives:
- Is the traditional two-trial approach the most cautious approach with highest probability of full drug approval?
- The additional statistical and operational complexities for a 1-trial strategy
- With the FDA’s changing requirements regarding dose optimization for oncology drugs rather than just carrying 1 dose and regimen forward for further clinical development after a dose escalation study, could this 1-trial approach include dose selection based on the AA endpoint?
Speakers:
- Everardo Saad, MD: Medical Director, IDDI
- Elisabeth Coart, PhD: Director Statistical Consulting & Research, IDDI
- Leandro Garcia Barrado, PhD: Senior Research Biostatistician, IDDI
- Moderator: Erik Falvey, Sr. Director Business Development Europe, IDDI
Accelerated Approvals (AA) is an IDDI’s Podcast series brought to you by our leading experts in regulatory statistics and clinical development strategy. This series delves into the mechanisms behind AA, spotlighting the regulatory processes that speed up access to groundbreaking therapies and how IDDI can optimize your clinical development path and reduces time to market.
The podcast series includes six episodes: