Podcast Series: Accelerated Approvals – Role of Randomization

The third episode of the IDDI Podcast Series: Accelerated Approvals delves deeper into the fact that FDA has explicitly stated a preference for randomized evidence when granting accelerated approvals.

Key Learning Objectives:

  • Is a single-arm trial still an option for AA?
  • How would a randomized confirmatory trial in a 2-trial approach be different from a randomized trial in a 1-trial approach?

Speakers: 

  • Everardo Saad, MD: Medical Director, IDDI
  • Elisabeth Coart, PhD: Director Statistical Consulting & Research, IDDI
  • Vaiva Deltuvaite – Thomas: Senior Scientist – Statistical Consultancy, IDDI
  • Moderator: Erik Falvey, Sr. Director Business Development Europe, IDDI

LISTEN TO THE PODCAST NOW →


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:

Stay Tuned!
Podcast Series: Accelerated Approvals | Episode 3: Role of Randomization