Accelerating Clinical Trials in the EU (ACT EU) initiative launch

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have launched an initiative to transform clinical trials within the European Union (EU).

The Aim of Accelerating Clinical Trials in the EU (ACT EU) is to change how trials are initiated, designed and run to develop the EU as a focal point for clinical research, further promote the development of high quality, safe and effective medicines, and better integrate clinical research in the European health system.

The EMA stated that, building on the application of the Clinical Trials Regulation (CTR) and the launch of the Clinical Trials Information System (CTIS) on 31 January 2022, 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 ACT EU strategy paper lists ten priority actions for 2022/2023:

1. Map existing initiatives and develop a governance rationalisation strategy (aligning different expert groups and working parties in the EMRN and ethics infrastructure)
2. The successful and timely implementation of the CTR and its implementing acts
3. Establish a multi-stakeholder platform, including patients, after stakeholder analysis
4. Implementing the GCP modernisation informed by the development of guidance at ICH
5. Analyse clinical trial data leveraging academic, non-profit, European and international initiatives, improving the impact of policymaking and funding on research outputs to support evidence-based decision making
6. Plan and launch a targeted communication campaign to engage all enablers (including data protection experts, academia, small and medium-sized enterprises [SMEs], funders, Health Technology Assessment (HTA) bodies, healthcare professionals)
7. Reinforce the co-ordination between scientific advice on clinical trial approval and design, and link to the methodologies working party domain
8. Develop and publish key methodologies guidance eg, on artificial intelligence (AI)/machine learning (ML) impacted clinical trials, complex trials, decentralised clinical trials and In Vitro Diagnostic Medical Devices Regulation (IVDR)/CTR interface (to strengthen links between innovation and scientific advice fora)
9. Successfully establish clinical trial safety monitoring and bridge to the EU4Health Joint Action and start its integration into a pre- and post-marketing safety monitoring framework
10. Deliver a clinical trials training curriculum including modules on drug development and regulatory science with links to universities and SMEs (serving as an educational ‘ecosystem’)

Together, said the EMA, these actions will contribute to achieving the ambitious goals for innovation in clinical trials set out in the European medicines agencies network strategy (EMANS) to 2025 and the EC’s Pharmaceutical Strategy.

ACT EU will be co-led by the EC, EMA and HMA, who have also collaboratively developed the initiative.