Decentralization of Clinical Trials: Opportunities, Risks and Development Paths Chiara CREPALDI a,1 , Alessandro VENTURI b , Luisa BROGONZOLI a and Maria Rosaria IARDINO a a Fondazione The Bridge b IRCSS Policlinico San Matteo Pavia-Università di Pavia ORCiD ID: Chiara Crepaldi https://orcid.org/0009-0005-8144-1936, Alessandro Venturi https://orcid.org/0000-0003-4415-1057, Luisa Brogonzoli https://orcid.org/0009-0004-0510-3559 Abstract. 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, Opportunities, Risks, European Health Data Space 1. Introduction 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 or organizing trials that meet the needs of both companies and patients involved. From this point of view, Covid-19 has made it possible for European countries to see the importance of the digitalization of health information and at the same time the difficulties of accessing and sharing such data due to the complexity of rules, and in many cases the inadequacy and lack of interoperability of infrastructures and processes. The Decentralized Clinical Trials (DCT) represent an important turning point because they include the use of digital technologies, remote connections with the patient, dispensing and administration of therapies at home or in contexts other than the research centers and hospitals. This evolution is proving to have a significant impact on the different stakeholders involved. The study deepened the impact of the digitization and decentralization of clinical trials for patients directly involved, and more generally 1 Crepaldi Chiara, Fondazione The Bridge. Email: c.crepaldi@fondazionethebridge.it. Healthcare Transformation with Informatics and Artificial Intelligence J. Mantas et al. (Eds.) © 2023 The authors and IOS Press. This article is published online with Open Access by IOS Press and distributed under the terms of the Creative Commons Attribution Non-Commercial License 4.0 (CC BY-NC 4.0). doi:10.3233/SHTI230480 269