Meeting Summary
The ACT EU Multi-Stakeholder Platform (MSP) held its annual meeting on 29 October 2025, bringing together regulators, ethics committees, patients, industry, academia, healthcare professionals and funders to advance Europe’s clinical trials ecosystem. Innovation was the central theme across four sessions.
The European Industry Pharmacist’s Group (EIPG) is an ad hoc member of the ACT-EU MSP and meets with industry representatives to develop a unified industry voice.
Keynote
Delivered by EFPIA, the keynote drew parallels between the healthcare ecosystem and the ocean: both are dependent on balance and interdependence.
AI was positioned not as a future aspiration but as an already-embedded component of clinical research, with a strong call for ethical integrity, human oversight and transparent governance to accompany its adoption.
Session 1: Innovation in Patient-Oriented Research
The session emphasised moving from patient consultation to genuine co-creation.
Patient experience data (PED) should be integrated throughout the medicine lifecycle, with early involvement, capacity building and representative participation as core principles.
Session 2: Convergence of Innovative Methodology and Biotechnology
Adaptive, platform- and model-informed trial designs were highlighted as valuable but dependent on robust data standards, interoperable infrastructure, and early, coordinated dialogue between regulators and HTA bodies.
Operational fragmentation across Member States was identified as a persistent barrier.
Session 3: Innovation in AI and Digitalisation
The European Health Data Space (EHDS) was identified as a transformative opportunity for patient-mediated data sharing and trial recruitment.
Calls were made for clearer guidance that aligns GDPR, MDR, and the AI Act, alongside sustained investment in digital infrastructure and cybersecurity.
Session 4: Innovation in Ethics
This was the session at which EIPG was engaged in the panel discussion on behalf of the industry.
The session addressed the growing complexity of ethical oversight in the context of AI, adaptive trials and decentralised models.
Key themes included the need for proportionate, two-stage ethics review processes; broader multidisciplinary expertise within ethics committees (including data science, AI and cybersecurity); and clearer responsibility frameworks for decentralised trials.
Critically, informed consent was reframed as a continuous, participant-centred process rather than a one-time event, supported by digital tools but grounded in human interaction.
Europe’s cultural pluralism was acknowledged as a strength, with coordination across Member States to focus on sharing best practice rather than rigid centralisation.
Closing
The meeting concluded with a reaffirmation of ACT EU’s collaborative mission and a call for cultural change – simplification, trust and genuine patient partnership – as the foundation for a competitive, patient-centred European clinical research environment. The ACT EU workplan for 2026–2027 is being finalised in Q1 2026.
