Public consultation on a multi-stakeholder platform to improve clinical trials in the EU

3 February 2023

On 3 February 2023, EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are launching a public consultation on the establishment of a multi-stakeholder platform to improve clinical trials in the European Union (EU). The multi-stakeholder platform is a deliverable of the joint initiative Accelerating Clinical Trials in the EU (ACT EU).

Successful clinical trials require the collaboration of a wide range of stakeholders. The creation of a common platform will encourage interactions between stakeholders at EU level, promoting a shared understanding and enabling concerted action to improve the clinical trials landscape for the benefit of innovation and all European citizens.

Stakeholders are invited to send their comments on the Priority Action 3 concept paper: an EU multi-stakeholder platform for improving clinical trials - Accelerating Clinical Trials in the European Union (ACT EU), advise on the key priorities for discussion and express their interest to join the platform via an online form until 3 March 2023 at midnight CET.

Experience with the COVID-19 pandemic has demonstrated the need to accelerate change and innovation in the way that clinical trials are designed, regulated, and conducted to maximise their efficiency and improve patient access to treatments. The multi-stakeholder platform will support discussions across the clinical research landscape, facilitate the evolution of clinical trial methods and approaches, help identify areas for progress, and find practical solutions to enable and drive change.

Participants in the platform will meet regularly to discuss key priorities and will be supported by topic groups responsible for technical discussions. Following the public consultation, a kick-off meeting will be held during the second quarter of 2023.

ACT EU

ACT EU is a collaboration between the EC, HMA and EMA that seeks to transform how clinical trials are initiated, designed, and run. The initiative was launched in January 2022 and aims to further develop the EU as a focal point for clinical research, to promote the development of high-quality, safe and effective medicines, and to better integrate clinical research in the European health system. ACT EU features ten priority action areas that are the basis for the ACT EU multi-annual workplan 2022-2026.