The pandemic period represented, from many points of view, an opportunity for the updating of research processes, simplifying paths and highlighting the need to reflect on new ways of designing and organizing clinical trials. Starting from a literature analysis, a multidisciplinary working group composed of clinicians, patient representatives, university professors, researchers and experts in the field of health policy, ethics applied to health, digital health, logistics confronted with respect to the positive aspects, critical issues and risks that decentralization and digitalization can imply for the different target groups. The working group proposed feasibility guidelines of decentralized protocols for Italy, developing reflections that may be relevant also for other European countries.
Keywords: Decentralised clinical trials; European Health Data Space; Opportunities; Risks.