Parkinson’s Europe has welcomed the recent release of an ACT EU (Accelerate Clinical Trials in the EU) plan to change how clinical trials are designed and run in the European Union (EU) over the next four years.
ACT EU was initially launched by the European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) back in January just before the Clinical Trials Regulation (CTR) came into force.
ACT EU was created to: transform how clinical trials are initiated, designed and run; further develop the EU as a focal point for clinical research; promote the development of high-quality, safe and effective medicines, and better integrate clinical research in the European health system. It is intended to strengthen the European environment for clinical trials, while maintaining a high level of protection of trial participants, data robustness and transparency.
It is hoped that such moves will speed the development of effective new treatments for EU citizens with all kinds of conditions, with people with Parkinson’s among those to benefit.
The release of the ACT EU 2022-2026 workplan details the vision for the next four years, based on ten priority actions.
The ACT EU focus for 2023 includes the following areas:
- Large, multinational clinical trials: establishing a support process specifically aimed at academic sponsors in order to make the EU a more attractive region to conduct clinical research;
- Implementation of the CTR: a particular focus on Clinical Trials Information System (CTIS) and CTR training activities and trouble-shooting any issues encountered by clinical trial sponsors;
- Multi-stakeholder platform: to facilitate the evolution of the clinical trials environment through regular dialogue between all stakeholders, including patients, healthcare professionals and academia, to find practical solutions to enable and drive change;
- Modernisation of good clinical practice: ACT EU will support not only the adoption but also the implementation of revised EU guidelines in technology and clinical trial design;
- Facilitation of innovative clinical trial methods: the initiative will issue guidance on decentralised clinical trials by the end of 2022 and publish a methodology roadmap to identify and prioritise key advances in clinical trial methods.
- Responding to the release of the ACT EU workplan, Russell Patten, the Director General of Parkinson’s Europe, said: “On behalf of the Parkinson’s community and its members, I warmly welcome and congratulate the European Union for having proposed the Accelerate
- Clinical Trials (ACT EU) initiative, which should go a long way to promote the development of high-quality, safe, and effective medicines for patients across Europe.
“The proof of course is in the pudding, and we will be watching closely to see if this initiative will increase large multi-state clinical trials, as these will undoubtedly support a more responsive research environment, reduce costs, and hopefully speed up processes and maybe even bring new medicines and refinement of existing medicines quicker to the table.
“People with Parkinson’s, as all patients, cannot wait years for a new medicine and the Covid-19 pandemic has demonstrated what amazing things can be done. Let’s use this spirit of helping people, first and foremost, while of course ensuring the continued high level of safety. We also need to make sure, as the initiative indicates, that the patient is placed at the heart of the consultation process, including recruiting patients in trials, to ensure that patient-orientated medicines come to market quickly, effectively, and safely. Parkinson’s Europe very much looks forward to participating in the multi-stakeholder platform.”
Amelia Hursey, Research Manager at Parkinson’s Europe, added: “It’s fantastic to see the major organisations of Europe coming together and prioritising clinical research. It’s a real step forward to helping our community have more access to research in the near future. This commitment demonstrates how important it is to have clinical research supported by policy makers and licensing organisations.”
Read the ACT EU 2022-2026 workplan
