The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT EU).
ACT EU, launched in January 2022, seeks to transform how clinical trials are initiated, designed and run. The aim is to further develop the EU as a focal point for clinical research, promote the development of high-quality, safe and effective medicines, and to better integrate clinical research in the European health system. ACT EU will strengthen the European environment for clinical trials, whilst maintaining the high level of protection of trial participants, data robustness and transparency that EU citizens expect.
The multi-annual ACT EU workplan builds on the Clinical Trials Regulation (CTR), which became applicable in January 2022, and on the activities of the European regulatory network to support clinical trials. The workplan highlights key focus areas such as innovation in clinical trials, robust methodologies and collaboration across stakeholders.
The ACT EU workplan is structured in line with the ten priority actions for ACT EU and has been prepared based on the recommendations of the European medicines agencies network strategy to 2025 and the European Commission’s Pharmaceutical Strategy for Europe.
The workplan lays out deliverables and timelines. In 2023, they include:
- Large, multinational clinical trials: establishing a support process specifically aimed at academic sponsors in order to make the EU a more attractive region to conduct clinical research;
- Implementation of the CTR: a particular focus on Clinical Trial Information System (CTIS) and CTR training activities and trouble-shooting any issues encountered by clinical trial sponsors;
- Multi-stakeholder platform: will be established in 2023 to facilitate the evolution of the clinical trials environment through regular dialogue between all stakeholders, including patients, healthcare professionals and academia, to find practical solutions to enable and drive change;
- Modernisation of good clinical practice: ACT EU will support not only the adoption but also the implementation of revised EU guidelines in technology and clinical trial design;
- Facilitation of innovative clinical trial methods: the initiative will issue guidance on decentralised clinical trials by the end of 2022 and publish a methodology roadmap to identify and prioritise key advances in clinical trial methods.