HEU-EFS at the ESC Cardiovascular Round Table with EMA

Advancing Patient-Centered Innovation

The HEU-EFS consortium was proud to be represented at the European Society of Cardiology Cardiovascular Round Table (CRT) meeting with the European Medicines Agency (EMA) in Amsterdam. This high-level event brought together leading voices from cardiology, regulatory bodies, industry, and patient communities to explore how Patient Experience Data (PED) and Patient Reported Outcomes (PROs) can shape the future of cardiovascular care.

Notably, Maria Luisa Buzelli (SDA Bocconi) and Prof. Piotr Szymański, Advisory Board member of HEU-EFS and Chair of the ESC Regulatory Affairs Committee (2024–2026), contributed to the discussions, reinforcing the consortium’s commitment to regulatory innovation and patient-centered research.

Key Outcomes from the Round Table

The roundtable featured open and constructive dialogue on the role of PED and PROs in clinical trials and regulatory decision-making. Highlights included:

• Elevating PROs to Primary Endpoints
  There is growing consensus that Patient-Reported Outcomes (PROs)—including quality of life, fatigue, and symptom burden—should be recognized not merely as supportive data but as primary endpoints in cardiovascular clinical trials. This shift reflects a broader commitment to capturing outcomes that matter most to patients.
• Patient Experience Data (PED) as a Lens on Real-World Impact
  Patient representatives provided compelling narratives illustrating how PED can reveal treatment effects that traditional clinical endpoints may overlook. These insights underscore the value of integrating lived experiences into evidence generation.
• Regulatory Alignment and Openness
  EMA representatives reaffirmed their commitment to incorporating PED and PROs into regulatory decision-making. Ongoing initiatives aim to refine methodologies and frameworks that support this integration.
• Strategic Role of ESC Volunteers
  ESC volunteers are instrumental in operationalizing patient engagement. By identifying and preparing patient contributors with relevant clinical experience and communication skills, they ensure that patient voices are authentically and effectively represented in ESC initiatives

As Prof. Szymański noted, “This is a pivotal moment for aligning regulatory science with what truly matters to patients.”

Why This Matters for HEU-EFS

The HEU-EFS project is deeply aligned with these goals. By integrating patient perspectives into the design and evaluation of future cardiovascular therapies, HEU-EFS aims to ensure that innovation translates into meaningful patient benefit. The CRT meeting served as a powerful platform to showcase this vision and to engage with key stakeholders shaping the future of cardiovascular regulation.

Innovative Health Initiative (IHI) MedTech Europe EFPIA – European Federation of Pharmaceutical Industries and Associations COCIR EuropaBio – the European Association for Bioindustries Vaccines Europe

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