Tune in to Episode 4 of IDDI Podcast Series Accelerated Approvals to explore the significant role of Endpoints in securing AA!
Key Learning Objectives:
- What primary endpoints are acceptable for trials leading to accelerated approval?
- What are the statistical considerations related to endpoints when a goal is accelerated approval using a one-trial or using a two-trial approach?
- The issue of using PFS for AA and for full approval
Speakers:
- Everardo Saad, MD: Medical Director, IDDI
- Vincent Staggs: Senior Scientist, Statistical Consulting, IDDI
- Sarah Hale: Associate Director, Biostatistical Services, 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: