The Accelerating Clinical Trials in the EU (ACT EU) initiative has established a multi-stakeholder platform (MSP) aimed at improving the environment for clinical trials across the European Union (EU). ACT EU is a collaboration between EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC), which seeks to transform how clinical trials are initiated, designed, and run.
During the first meeting of the MSP advisory group that officially kicks-off the platform, María Jesús Lamas, director of the Spanish agency of medicines and medical products, who is regulatory co-chair of the group, said:
The establishment of the multi-stakeholder platform is an important milestone for ACT EU. Our collaborative efforts will drive progress towards more streamlined and efficient clinical trials and allow patients and citizens to benefit from clinical research in Europe.
The launch of the MSP fosters collaboration and promotes open dialogue around the challenges and opportunities represented by advances in clinical trials regulation, methodologies, and technology for the benefit of EU citizens. It follows a public consultation and a workshop organised in 2023.
The MSP is a key part of ACT EU, providing a platform for stakeholders to exchange views on all aspects of clinical research. Topics for discussion include clinical trial design, conduct, statistical analysis, proposals for regulation optimisation, transparency of data, and patient engagement.
The MSP advisory group provides strategic and operational advice to the ACT EU programme. It comprises representatives from key stakeholder groups directly impacted by clinical trial-related activities in the EU and will meet regularly to build mutual trust and discuss key priorities. Following the inaugural meeting of the advisory group, a stakeholder co-chair will be appointed in May.
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 11 priority action areas that are the basis for the ACT EU multi-annual workplan 2023-2026.