October 7, 2025
Title: The Value of ECAs for Regulatory and HTA Evidence Needs
Tuesday, October 7, 2025
10:00AM EDT | 2:00PM UTC | 4:00PM CEST
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Registration coming soon.
Description
This webinar explores the value of External Control Arm (ECA) studies which are gaining traction as part of evidence generation strategies in drug development, yet their true value remains a topic of considerable discussion. As the industry grapples with the integration of real-world evidence (RWE) in drug development and commercialization, understanding when and how ECAs successfully contribute to regulatory, health technology assessment (HTA), and clinical decision-making has become increasingly important.
In this webinar, speakers offering diverse stakeholders' perspectives will critically examine the value of ECAs by framing their investments (costs, data access, development timelines, and stakeholder engagement) versus the potential payoff (faster approvals, smaller or fewer randomized trials, stronger contextual evidence for single-arm trials, and enhanced confidence in the totality of the evidence). Speakers will share their wide-ranging experience with ECA design and evaluation as well as their forward-looking view on the role of ECAs in the mandatory European Union (EU) HTA Joint Clinical Assessment (JCA) of oncology and advanced therapy drugs.
Attendees will leave with a clearer understanding of the conditions under which ECAs are most likely to deliver return on investment (ROI) as part of a complete evidence package, including insights into HTA and regulatory variability and future opportunities like the evolving EU JCA landscape.
Learning Objectives
- Articulate key considerations for investing in ECAs across regulatory and HTA environments including data quality, cost, and potential for expedited decision- making.
- Examine variability in ECA acceptance and identify conditions in which ECAs meaningfully impact payer, regulatory and clinical decision-making.
- Draw learnings from shared examples and experience to maximize ROI of ECAs, and anticipate how evolving policies, such as EU JCA, may affect future evidence planning.
Moderator:
Alexandra Sosinksy, ScM, Senior Director, Genesis Research Group, Hoboken, NJ, USA
Speakers:
Frank-Ulrich Fricke, PhD, Dean, Technische Hochschule Nürnberg and Arbitration Board on Drug Prices, Nuremberg, Germany
Mira Pavlovic, MD, Director, Centre Sabouraud, Saint-Louis Hospital, Paris, France and Lisbon University, Lisbon, Portugal
Sponsored by Corporate Partner, Genesis Research Group
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.