ISPOR hosts expert webinar exploring the value of ECAs for regulatory and HTA evidence needs
September 12, 2025 | EU, HTA, JCA, RWE, eca, external control arms, health technology assessment, real-world evidence, regulatory
On Tuesday, October 7th, you are invited to join a Genesis Research Group-led webinar exploring the value of External Control Arm (ECA) studies. Gaining traction as part of evidence generation strategies in drug development, the true value of ECAs 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.
Speakers:
Alexandra Sosinksy, ScM, Senior Director, Genesis Research Group, Hoboken, NJ, USA
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
Description
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.
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This content was provided by Genesis Research Group
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