EU regulators release new workplan for accelerating clinical research

The 2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT EU) has been published by the European Commission (EC), Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA).

Launched in January, ACT EU aims to transform how clinical trials are initiated, designed and run, building off of the Clinical Trials Regulation (CTR) and Clinical Trials Information System (CTIS) which became applicable in the same month.

The objective 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. While strengthening the European environment for clinical trials, the initiative also aims to maintain the high level of protection for trial participants, data robustness and transparency.

The multi-annual ACT EU workplan highlights key focus areas such as clinical trial innovation, robust methodologies and collaboration across stakeholders.

The new workplan lays out deliverables and timelines, for 2023 these include:

• establishing a support process specifically aimed at academic sponsors in order to make the EU a more attractive region to conduct large, multinational clinical trials
• implementing the CTR – focus on CTIS and CTR training activities and trouble-shooting any issues encountered by trial sponsors
• establishing a multi-stakeholder platform to facilitate the evolution of the clinical trials environment through regular dialogue between all stakeholders, including patients, healthcare professionals and academia
• modernising good clinical practice – supporting the adoption and implementation of revised EU guidelines in technology and clinical trial design
• issue guidance on decentralised clinical trials by the end of 2022 and publish a methodology roadmap to identify and prioritise advances in clinical trial methods

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 EC’s Pharmaceutical Strategy for Europe.