ACT EU Multi-Stakeholder Platform Annual Meeting

Published on 10/11/2025
Amelie at ACT EU

ECRIN's Head of Clinical Operations Amelie Michon attended the ACT EU Multi Stakeholder Platform conference, which hosted over 60 stakeholders face to face in Amsterdam and 200 more online. 

The meeting focussed on innovation in clinical trials in four area: patient engagement; methods; data and AI, and; ethics. Amelie moderated Session 3: Innovation in AI and digitalisation with Peter Arlett, EMA's Head of Data Analytics and Methods Task Force. 

The session was about how AI and digital tools are now reshaping the design and conduct of clinical trials in Europe. Very insightful examples were shared by representatives of the different stakeholder groups highlighting both challenges and opportunities related to data quality, interoperability, regulatory compliance and trust.

Peter Arlett shared a few of his other take home messages, including:

  • Clear alignment to a common vision for better, faster and smarter clinical trials in the EU.
  • Need to engage patients early and meaningfully in the clinical research pathway and to enable effective engagement with knowledge shared beyond individual trials.
  • There is an opportunity to leverage the EHDS to bring together clinical trials and the world of data from routine healthcare: this can speed up recruitment and enrich the following up and data for analysis.
  • Innovative trial methods are already here; now we need a mindset shift to truly bring them to patients.
  • AI in clinical trials is a reality today. There were calls for sharing good practice, developing guidance, and moving from pilots to routine practice.
  • Ethical reflection in clinical research is critical. In our efforts to improve clinical research in the EU, we must ensure the ethics voice is heard and any efforts to speed up assessment must go hand in hand with simplification.
  • Further work on ethics good practices at EU level will bring high value.

This is definitely a topic that deserves a multi-stakeholder collaborative approach to move forward on an ethical and responsible manner.