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).
Traditionally, clinical trials have been conducted at specific clinical trial sites, to which patients had to travel. 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. The 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.