EMA announces publication of recommendations to facilitate decentralized clinical trials in the EU

EMA/HMA/EC jointly publish a recommendation paper on decentralized clinical trials in the EU designed to safeguard the rights and well-being of participants as well as the reliability and robustness of the data collected.

At the close of 2022, the European Medicines Agency (EMA) announced joint publication of a Recommendation paper on decentralized elements in clinical trials by the European Commission (EC), the Heads of Medicines Agencies (HMA) and the EMA. The recommendations were put together by the European Medicines Regulatory Network (EMRN), under the joint initiative Accelerate Clinical Trials in the European Union (ACT EU).

Clinical trials have traditionally been conducted at specific sites that all participants travel to. The innovation of decentralized clinical trials (DCTs) is easing trial participation by removing the need for travel to central trial sites. The goals of this approach are to make clinical trials available to a wider demographic of participants and to reduce drop-out rates.

The advancement of digital tools and telemedicine are enabling the decentralization of clinical trials. Elements of decentralization include remote monitoring and diagnostics, electronic informed consent, home health visits and direct-to-patient shipment of study drugs.

The new recommendations include an overview of national provisions for specific decentralization elements to be used in DCTs. The aims of the recommendations are to facilitate the conduct of DCTs whilst safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected.

The drafting of the paper was overseen by HMA’s Clinical Trials Coordination Group, drawing together contributions from the experts of EMRN, including representatives responsible for the authorization of clinical trials, members of ethic committees, good clinical practice inspectors, methodology experts and patient organizations. This important first-step paper of recommendations is intended as a living document that will be continuously developed as experience is gained and knowledge increases.