At the 42nd National Congress of the Italian Society of Pharmacology, which was held in Sorrento, Italy, November 13-16, 2024, Veronica Rivi, from the Department of Biomedical, Metabolic and Neuroscience Sciences at UNIMORE and a member of FACILITATE, presented a poster entitled ‘Embracing the healthcare digital revolution: pioneering an ethical and legal framework for clinical data return’.
The exponential growth of qualitative and quantitative health data presents both unprecedented opportunities and challenges in clinical research. Within the realm of P4 medicine – embracing predictive, preventive, personalized, and participatory approaches – the healthcare digital revolution demands a trusted ethical, legal, and regulatory ecosystem for clinical trial data governance. Moreover, technological solutions are essential to support ethical data sharing and reuse.
Central to this revolution is the empowerment of patients, who now play an active role in shaping the strategy and design of clinical trials, with newfound rights and responsibilities in the drug development process. Establishing a social alliance among all study participants – patients, healthcare professionals, regulators, and pharmaceutical companies – is thus a primary objective in clinical research.
In response to this need, the Innovative Health Initiative (IHI) recently launched the FACILITATE project. This project aims to establish a transparent and accountable framework for data sharing in clinical research across European Member States. By fostering integrity, transparency, inclusivity, and reciprocity, FACILITATE endeavors to ensure ethical, person-centered clinical research and navigate the complexities of building a robust social alliance during the digital healthcare revolution.
Recognizing that the future of participatory clinical research hinges on cultivating and sustaining social alliances, FACILITATE engages a multidisciplinary team from diverse sectors, including industry, academia, advocacy groups, non-profit organizations, and regulatory agencies. Through the creation of a roadmap that integrates legal, ethical, and technological considerations, FACILITATE is developing a social alliance adaptable to the evolving landscape of clinical research. This initiative is responsive to the imperative for more efficient and ethical strategies for data sharing and participant protection.
