Friends of Cancer Research (Friends) convened a public meeting, “Application of External Control Arms in Oncology Drug Development” to explore opportunities for advancing the use of external control arms (ECAs) to enhance oncology drug development. ECAs are constructed from existing data sources such as prior clinical trials or real-world data and can provide valuable insights for evaluating new therapies, particularly when traditional randomized trials are impractical. The event featured new results insights from Friends’ ongoing ECA research partnership aimed at advancing best practices for generating rigorous, reliable evidence through ECAs. Discussions focused on how these approaches can support regulatory decision-making and help expand patient access to promising treatments. Explore the meeting panelists and agenda below.

9:30AM | Networking Breakfast

10:00AM | Welcome & Opening Remarks

10:05AM | Keynote Fireside

• Michael McCaughan, Prevision Policy – Moderator 
• Amy Abernethy, Highlander Health

10:25AM | Session 1 – Methodological and Data Insights from the ECA Pilot Project

Session 1 provided an overview of the ECA Pilot Project, including its design, data sources, analytic approach, and key findings; highlighting the methodological and operational lessons that emerge across ECAs; and establishing a shared foundation for subsequent discussions on drug development applications and policy considerations.

• Elizabeth Garrett-Mayer, American Society of Clinical Oncology – Moderator
• Ruthie Davi, Medidata, a Dassault Systèmes company
• Janet Espirito, Ontada
• Brad Karalius, AstraZeneca
• Cassadie Moravek, Pancreatic Cancer Action Network
• Jennifer R. Rider, ConcertAI
• C.K. Wang, (COTA) Verana Health

11:25AM | Break

11:40AM | Session 2 – Translating Evidence to Practice: Integrating ECAs into Oncology Drug Development

Session 2 explored how ECAs can be integrated into oncology drug development programs, including specific use cases, operational and analytic considerations, and opportunities to apply lessons from the pilot to support more efficient, interpretable, and patient-centered clinical trials.

• Ashita Batavia, J&J Innovative Medicine – Moderator
• Pete Ansell, AbbVie
• Jaclyn Bosco, IQVIA
• Marie Bradley, FDA
• Neal J. Meropol, Flatiron Health
• Jane Perlmutter, Patient Advocate

12:30PM | Lunch & Networking

1:10PM | Session 3 – Policy Perspectives and Regulatory Priorities for ECAs

Session 3 examined the policy landscape surrounding ECAs, discussed emerging regulatory considerations and stakeholder priorities, and identified opportunities to align expectations, strengthen transparency, and advance responsible and scalable use of ECAs in oncology clinical trials.

• Clay Alspach, Leavitt Partners and ACRO – Moderator
• Amy Comstock Rick, FDA
• Joe Franklin, Biotechnology Innovation Organization
• Mark Lee, N-Power Medicine
• Donna Rivera, Canal Row Advisors

1:55PM | Closing Remarks

2:00PM | Meeting Adjourned