The EU Reinvents Itself to Lead the Development of Clinical Trials

The European Commission (EC) and the European Medicines Agency (EMA) have published the 2022-2026 roadmap of the Accelerating Clinical Trials in the EU (ACT EU) initiative that aims to transform the way clinical trials are initiated, designed, and executed in the European Union.

The horizon of this initiative aims to make the EU “a focal point for clinical research, promote the development of high quality, safe and effective medicines, and improve the integration of clinical research into the European healthcare system.”

ACT EU explains the EMA, will strengthen the European environment for clinical trials while maintaining the high level of protection for trial participants, the robustness of data, and transparency expected by EU citizens.

The ACT EU multi-year work plan builds on the Clinical Trials Regulation (CTR), which entered into force in January 2022, and the activities of the European regulatory network to support clinical trials. The work plan highlights key focus areas, such as innovation in clinical trials, robust methodologies, and collaboration between stakeholders.

The work plan is structured according to the ten ACT EU priority actions and has been prepared based on the recommendations of the European Medicines Agency Network Strategy 2025 and the European Commission’s Pharmaceutical Strategy for Europe.

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The work plan sets out deliverables and timelines for clinical trials

The following are planned for 2023: Large multinational clinical trials: the establishment of a support process specifically targeting academic sponsors in order to make the EU a more attractive region to conduct clinical research. CTR implementation: a particular focus on the Clinical Trials Information System (CTIS) and CTR training activities and the resolution of any issues encountered by clinical trial sponsors.

Multi-stakeholder platform: to be established in 2023 to facilitate the evolution of the clinical trial environment through regular dialogue between all stakeholders, including patients, healthcare professionals and academics, to find practical solutions to enable and drive change. Modernization of good clinical practice: ACT EU will support not only the adoption but also the implementation of the revised EU guidelines on clinical trial technology and design.

And finally, facilitation of innovative clinical trial methods: the initiative will issue guidance on decentralized clinical trials by the end of 2022 and publish a methodological roadmap to identify and prioritize key advances in clinical trial methods.

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