September 30, 2026
Title: Creating Defensible Evidence With External Control Arms
Wednesday, September 30, 2026
1:00PM EDT | 5:00PM UTC | 7:00PM CEST
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Description
As precision medicine and targeted therapies reshape drug development, traditional phase III trials are becoming increasingly difficult to justify. Smaller patient populations, challenges in control arm accrual, rising development costs and the urgency to bring potentially curative therapies to patients are driving demand for alternative evidence-generation approaches. External control arms (ECAs) have emerged as a promising strategy to accelerate development timelines, reduce trial burden and provide meaningful clinical context when traditional comparator arms are impractical. While ECAs are already being used to support regulatory discussions and supplement clinical evidence, the industry is now exploring how they can become more robust, defensible and widely adopted beyond regulatory decision-making.
This webinar will examine why ECAs should be considered more broadly across modern drug development and explore the methodological approaches needed to strengthen their credibility. We will discuss how to design robust, fit-for-purpose external control arms that can provide meaningful comparative evidence, support decision-making and better reflect real-world clinical practice. Join us to learn how the industry can increase confidence in ECAs and move closer to making them a trusted, defensible alternative to traditional randomized trials.
Learning Objectives
Understand how external control arms can help accelerate time to market while maintaining evidence quality and regulatory credibility.
Examine the evolution from traditional Phase III studies toward more pragmatic, patient-centered clinical trial models.
Identify methodological best practices for developing scientifically rigorous and defensible external control arms that can support regulatory submissions, comparative effectiveness assessments and real-world decision-making.
Identify the opportunities and challenges associated with broader adoption of ECAs across oncology and other therapeutic areas.
Moderator:
Amy Eaves, VP, Real-World Data and Evidence, Cardinal Health, Phoenix, AZ, USA
Speakers:
Bruce Feinberg, DO, Vice President and Chief Medical Officer, Cardinal Health, Atlanta, GA, USA
Harlen Hays, MPH, Sr. Director, Scientific Operations and Analytics, RWDE Innovation, Cardinal Health, Kansas City, MO, USA
Andrew Klink, PhD, MPH, Sr. Director, Business Development, Real-World Data and Evidence, Cardinal Health, Palm Springs, CA, USA
Sponsored by Corporate Partner, Cardinal Health.
Please note: On the day of the scheduled webinar, the first 1000 registered participants will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later date, the full-length webinar recording will be made available at the ISPOR Educational Webinar Series webpage approximately 2 days after the scheduled Webinar. Reservations are on a first-come, first-served basis.