Accelerating Clinical Trials in the European Union (ACT-EU)

The Multistakeholder Platform (MSP) and the position of the European Industrial Pharmacists Group (EIPG)

by Rebecca Rebecca Stanbrook

ACT EU aims to transform how clinical trials are initiated, designed and run to further promote the development of high quality, safe and effective medicines, and to better integrate clinical research in the European health system. The initiative seeks to deliver on the clinical trial innovation recommendations of the European medicines agencies network strategy and the European Commission’s Pharmaceutical strategy for Europe. It builds on the Clinical Trials Regulation (CTR) and Clinical Trials Information System’s (CTIS) launch on 31 January 2022.

The European Commission, EMA and Heads of Medicines Agencies (HMA) launched ACT EU in January 2022. For more information, see the ACT EU website: Accelerating Clinical Trials in the EU (ACT EU)

Workplan

The ACT EU workplan sets out deliverables and timelines for the programme for 2022-26.

The deliverables for 2023 included the following:

  1. Establishing a process to support academic sponsors in enabling large multinational clinical trials
  2. Supporting clinical trial sponsors to make best use of available CTIS and CTR training activities
  3. Setting up a multi-stakeholder platform to facilitate dialogue between clinical trial stakeholders, including patients, healthcare professionals and academia
  4. Modernising good clinical practice by supporting the adoption and implementation of revised EU guidelines in clinical trial design
  5. Facilitating innovation in clinical trial methods by publishing a methodology roadmap and further developing guidance on decentralised clinical trials

Work Plan Priority Actions in detail:

Priority Actions:

The ACT EU initiative has identified several priority actions to support its goals:

  1. Mapping and Governance: Establishing clear governance structures and mapping out the clinical trials landscape to streamline processes.
  2. Successful Implementation of CTR: Ensuring the effective implementation of the Clinical Trials Regulation across the EU.
  3. Multi-Stakeholder Platform: Creating a platform for dialogue among clinical trial stakeholders, including patients, healthcare professionals, and academia.
  4. Good Clinical Practice Modernisation: Updating and modernizing good clinical practice guidelines to reflect current needs and innovations.
  5. Clinical Trials Analytics: Enhancing the use of data analytics to improve the design and conduct of clinical trials.
  6. Targeted Communication Campaign: Raising awareness and understanding of clinical trials among stakeholders and the public.
  7. Scientific Advice: Providing scientific advice to support the development of innovative clinical trial methodologies.
  8. Support for Academic Sponsors: Assisting academic sponsors in conducting large, multinational clinical trials.
  9. Decentralised Clinical Trials: Promoting the use of decentralized clinical trial methods to increase efficiency and accessibility.
  10. Training and Education: Offering training and educational resources to improve the skills and knowledge of those involved in clinical trials.
  11. Regulatory Flexibility: Implementing lessons learned from the COVID-19 pandemic to create a more responsive regulatory environment.

EMA, the European Commission and the Heads of Medicines Agencies (HMA) published the workplan in August 2022.

As part of priority action 3 ACT EU initiated a multi-stakeholder platform to enhance dialogue among clinical trial stakeholders, including patients, healthcare professionals, and academia. As an ad-hoc member of the multi-stakeholder platform, the European Industrial Pharmacists Group (EIPG) plays a crucial role in this transformative journey. By participating in this initiative, EIPG contributes to the harmonization, innovation, and collaboration necessary to advance clinical research and improve healthcare outcomes across Europe.

Past Meetings

Since its inception, ACT EU has hosted several key meetings to drive its agenda forward. Notably, the first ACT EU Multi-Stakeholder Platform (MSP) workshop was held in June 2023. This workshop brought together various stakeholders to discuss transforming the EU environment for clinical trials, gather feedback from public consultations, and agree on a model for the MSP2. Additionally, the inaugural meeting of the MSP Advisory Group took place on March 20, 2024, followed by an ad-hoc representatives info session on April 11, 2024.

The next planned meeting of the MSP was on 4 July 2024, the minutes of this meeting are awaited.  Although this was not an annual meeting EIPG were invited as a suggestion of a topic was made, that was about the linking of the different initiatives within Europe which were not part of the ACT-EU workplan.  This also included a comment about the availability of data across the EU.  The minutes are currently under review and will be made available shortly- Adhoc members are routinely only invited to the annual meetings.

Future Meetings

Looking ahead, several important meetings are scheduled to continue the momentum of ACT EU. MSP Advisory Group and MSP annual meeting dates 2024-2026 (europa.eu) The next virtual meeting is planned for 27 September, where there is a call for agenda items.  The annual meeting F2F will take place on 22 October 2024.

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