Episode 8: Accelarating Clinical Trials in the EU (ACT EU)

Accelarating Clinical Trials in the EU (ACT EU) is an initiative aimed at transforming how clinical trials are initiated, designed, and run in the European Union. Here's a summary of its key aspects:

1. Purpose: ACT EU was launched on January 13, 2022 to make the EU a more attractive and favorable environment for conducting clinical trials, while maintaining high standards of participant protection and data reliability.

2. Collaboration: This initiative was introduced as part of a coordinated effort by the European Commission, the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) to transform how clinical trials are initiated, conducted, and reported in the European Union.

3. Implementation of the Clinical Trials Regulation: The launch of ACT EU coincided with the application of the Clinical Trials Regulation (Regulation (EU) No 536/2014), which became effective on January 31, 2022. This timing was strategic, as ACT EU was designed to support and enhance the implementation of this new regulation. ACT EU supports the effective application of Regulation (EU) No 536/2014, which aims to harmonize the assessment and supervision processes for clinical trials throughout the EU.

4. Strategic priorities: These include enhancing coordination among member states, improving efficiency in reviewing and authorizing trials, and promoting innovative trial designs.

5. Stakeholder engagement: The initiative involves collaboration with various stakeholders, including academic researchers, pharmaceutical industry, and patient organizations. Patient Centricity is a strong part of the initiative (Please see topic 10 below and please read also Episode 3 of this blog series Patient-centricity-in-clinical-trials/).

6. Digital infrastructure: ACT EU supports the development and implementation of the Clinical Trials Information System (CTIS), a centralized EU portal and database for clinical trials.

7. Capacity building: It focuses on strengthening the capacity of ethics committees and national competent authorities across the EU.

8. Transparency: Promoting greater transparency in clinical trial processes and results.

9. Global competitiveness: Aims to reinforce the EU's position as an attractive location for innovative medical research and development.

10. Patient-centric approach: Emphasizes involving patients in trial design and conduct, and improving access to clinical trials for EU citizens.

In summary, this initiative is part of the EU's broader strategy to enhance its pharmaceutical and healthcare innovation ecosystem.