The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) published on Monday 19 December, as part of the ‘ACT EU’ joint initiative to accelerate clinical trials in the European Union, recommendations to facilitate the conduct of decentralised clinical trials in the European Union and the European Economic Area.
The new approach should allow clinical trial participants to travel less frequently to centralised clinical trial sites. This approach has two objectives: to make access to clinical trials available to a larger number of participants and to reduce trial drop-out rates.
The decentralised approach is made possible by the advancement of digital tools such as telemedicine, electronic informed consent and more mobile healthcare such as the direct-to-patient delivery of study medicines.
The recommendations include an overview of relevant national provisions in the context of decentralised clinical trials.
The EMA states that the recommendations were developed by the European Medicines Regulatory Network with input from experts from regulatory authorities responsible for authorising clinical trials, members of ethics committees, good clinical practice inspectors, methodological experts and representatives of patient organisations. The drafting of the recommendations was coordinated by the Clinical Trials Coordination Group (CTCG).
These recommendations are subject to regular updates as knowledge advances.
Link to the recommendations: https://aeur.eu/f/4qo (Original version in French by Émilie Vanderhulst)