The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have launched an initiative to transform how clinical trials are initiated, designed, and run. This initiative, accelerating Clinical Trials in the EU (ACT EU), aims to further develop the European Union 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.

New European Clinical Trial Regulation

Building on the application of the Clinical Trials Regulation 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. For more information on the new European Clinical Trial Regulation, please read here.

Objectives of the ACT EU

The ACT EU strategy paper published lists ten priority actions for 2022/2023, including enabling innovative trial methods, establishing a multi-stakeholder platform, and supporting the modernisation of good clinical practice.

  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 by developing KPIs and
    dashboard to track performance of the European clinical trials environment; and including the promotion of
    larger, multinational trials specifically in the academic setting.
  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, SMEs, funders, HTA bodies, healthcare professionals).
  7. Reinforce the coordination between scientific advice on CT approval and CT design and link to the
    methodologies working party domain.
  8. Develop and publish key methodologies guidance e.g., on AI/ML impacted CTs, complex trials,
    decentralised CTs and IVDR/CTR interface (to strengthen links between innovation and scientific advice
  9. Successfully establish CT 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, they 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 European Commission’s Pharmaceutical Strategy.

For further information, please read here