In this ISPOR-hosted webinar, Alexandra Sosinsky, ScM, Frank-Ulrich Fricke, PhD, and Mira Pavlovic, MD, discuss the value of External Control Arms across regulatory and HTA environments.
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.
Learn to:
- 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.
- Learn from shared examples and experience to maximize ROI of ECAs, and anticipate how evolving policies, such as EU JCA, may affect future evidence planning.
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.
Please contact us if you have questions or would like a copy of the slides.
