The European Commission (EC), Heads of Medicine Agencies (HMA), and European Medicines Agency (EMA) have released the 2022–2026 workplan for the programme Accelerating Clinical Trials in the EU (ACT EU).
Building on the Clinical Trials Regulation (CTR) and Clinical Trials Information System (CTIS), which went into effect in the same month, ACT EU was established in January with the goal of revolutionising the way clinical trials are started, planned, and conducted.
The goal is to strengthen the EU’s position as a hub for clinical research, encourage the creation of high-quality, risk-free, and efficient medicines, and enhance the integration of clinical research into the European healthcare system. The project intends to retain the high degree of security for study subjects, data integrity, and openness while also improving the European ecosystem for clinical trials. The multi-annual ACT EU workplan includes important focus areas such as innovative clinical trials, reliable procedures, and stakeholder participation.
For 2023, the new workplan specifies the following deliverables and deadlines:
- Creating a support system expressly for academic sponsors to increase the EU’s appeal as a location for large, international clinical trials.
- Focus on CTIS and CTR training activities and problem-solving any challenges trial sponsors may run across while putting the CTR into practise.
- Creating a multi-stakeholder platform that would enable regular communication between all stakeholders, such as patients, healthcare workers, and academics, to assist the advancement of the clinical trials setting.
- Modernising best practises in clinical care by promoting the adoption and application of updated EU standards for technology and clinical trial design.
- To identify and prioritise improvements in clinical trial procedures, release guidelines on decentralized clinical studies by the end of 2022.
The ACT EU workplan, which was developed based on the conclusions of the European Medicines Agencies Network Strategy to 2025 and the European Commission’s Pharmaceutical Strategy for Europe, lists the 10 main tasks for ACT EU.