AIFA Agenzia Italiana del Farmaco
Decentralised clinical trials: the Recommendations of the European Medicines Regulatory Network
The European Commission (EC), the Heads of National Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations («Recommendation paper on decentralised elements in Clinical trials») that aim to facilitate the conduct of decentralised clinical trials (DCTs), safeguarding the rights and well-being of participants, as well as the robustness and reliability of the data collected.The recommendations were coordinated by the Clinical Trials Coordination Group (CTCG), with the participation of representatives of national regulatory authorities, members of Ethics Committees, Good Clinical Practice (GCP) inspectors, methodology experts and representatives of patient organizations and also include a recognition of national provisions on specific elements of DCTs.
The document is part of the objectives of the joint «ACT EU» initiative of the Regulatory Network (EMRN), launched on , simultaneously with the implementation of the new Regulation, to accelerate clinical trials in the European Union.
Decentralised clinical trials are characterised by a number of organisational arrangements and tools that allow, for example, to reduce the need for participants to travel to central trial sites. This is possible thanks to the advancement of digital tools, and to more mobile and local healthcare, which include, among other things, the possibility of home health visits, remote monitoring and diagnostics, direct shipment of study drugs to the patient and informed consent electronically.
This approach therefore helps to make clinical trials accessible to a wider number of patients and to simplify their participation.
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Source — https://www.univadis.it/viewarticle/sperimentazioni-cliniche-decentrate