The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralized clinical trials (DCTs) while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected. This is an outcome of their joint initiative to Accelerate Clinical Trials in the European Union (ACT EU).
World Duchenne Organization Board Member, and Duchenne CAB Coordinator Sally Hofmeister, has participated in this initiative. Additionally, the World Duchenne Organization is partner in the Trials@Home project, a EU-funded project researching the benefits from decentralized clinical trials.
Traditionally, clinical trials have been conducted at specific clinical trial sites, to which patients had to travel to. The aim of DCTs is to make it easier for patients to participate in clinical trials by reducing the need to travel to central trial sites. This approach has the potential to make clinical trials available to a wider demographic of participants and reduce drop-out rates.
Decentralization is enabled by the advancement of digital tools, telemedicine and more mobile and local healthcare. It includes aspects such as home health visits, remote monitoring and diagnostics, direct-to-patient shipment of study drugs and electronic informed consent.
The recommendations include an overview of national provisions for specific decentralized clinical trial elements to be used in clinical trials. They were put together by the European medicines regulatory network with experts from regulatory bodies responsible for the authorization of clinical trials, members of ethic committees, good clinical practice inspectors, methodology experts and representatives of patient organizations. Drafting of the paper was coordinated by the clinical trials coordination group (CTCG).
These recommendations under ACT EU are a first and important step towards clarifying the use of decentralized clinical trials in the EU/EEA by the European medicines regulatory network.
They are expected to evolve as knowledge increases and experience is gained. In particular, the overview of national provisions will be updated on a continuous basis.
ACT EU is a collaboration between the EC, HMA and EMA that seeks to transform how clinical trials are initiated, designed and run. The initiative was launched in January 2022 and aims to further develop the EU as a focal point for clinical research, to promote the development of high-quality, safe and effective medicines, and to better integrate clinical research in the European health system. 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/EEA citizens expect. ACT EU features ten priority action areas that are the basis for the ACT EU 2022-2026 workplan.