ACT EU: creating a better environment for clinical trials through collaboration

22 June 2023

The Accelerating Clinical Trials in the EU (ACT EU) initiative is today organising the kick-off workshop for a new multi-stakeholder platform to improve clinical trials in the European Union (EU). ACT EU is a collaboration between EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) that seeks to transform how clinical trials are initiated, designed, and run. The multi-stakeholder platform is a key deliverable of the initiative.

ACT EU aims to place stakeholders at the centre of its activities by giving them the opportunity to steer the direction of the programme. Today’s workshop will discuss best approaches to support the implementation of the clinical trial regulation including the role of ethics committees, support to non-commercial sponsors to increase the conduct of multinational clinical trials and how to optimise the coordination of scientific advice to support evidence generation.

Peter Arlett, Head of Data Analytics and Methods Task Force at EMA, said: “The multi-stakeholder platform will build consensus and enable new approaches to clinical studies positioning the EU as a preferred location for innovative clinical research.”

Björn Eriksson, HMA’s lead on clinical trials: “A successful clinical trials environment in all Member States will support bigger, better and faster clinical trials for better medicines for patients and drive innovation and investment.”

Sylvain Giraud, Head of Unit at the EC’s Directorate-General for Health and Food Safety: “The multi-stakeholder platform provides the opportunity for a dialogue at EU level to exchange on the implementation of the Clinical Trials Regulation and ensure compliance with its rules and modalities.”

A series of public events bringing together clinical trials stakeholders will be organised during 2023 and 2024 to discuss and agree the model for the establishment of the platform.

Background

ACT EU 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.