Cytel invites you to an interactive Office Hours session with James Matcham and Anupama Vasudevan, where you will have the opportunity to ask questions about regulatory readiness and evidence generation for External Control Arms (ECAs).

From evolving frameworks at the FDA, EMA, and MHRA to practical considerations for evidence generation and design, this is your chance to engage directly with experts and gain clarity on how ECAs can meet regulatory expectations.

Whether you are planning to integrate ECAs into your development strategy or refining an existing approach, bring your questions and leave with actionable insights to help you navigate this rapidly changing landscape.

What can you ask?

• How can we increase the likelihood of regulatory acceptance of an ECA for our asset or program?
• How should time-zero be defined for time-to-event endpoints in real-world data?
• What are the pros and cons of Bayesian borrowing versus using an ECA?
• What are the reasons to use an ECA constructed from prior RCT data (where RCTs were possible)?

Speakers

• James Matcham, Vice President, Innovative Statistics, Cytel
• Anupama Vasudevan, Senior Director, Real World Evidence, Cytel