Embracing the Healthcare Digital Revolution: pioneering an Ethical and Legal framework for Individual Participant Clinical Data Return

The exponential growth of qualitative and quantitative health data presents both unprecedented opportunities and challenges in pharmacology and 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 need to play an active role in shaping the strategy and design of clinical trials, with newfound rights and responsibilities in clinical studies and drug development. Establishing a social alliance (Blom et al., 2023) 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 Medicine Initiative (IMI), launched the FACILITATE project two years ago, to establish a transparent and accountable framework for data sharing in clinical research across European Member States. By fostering integrity, trustworthiness, 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, and co-creation 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. By putting patient participation at the center of the development of health research and giving them the confidence to shift from passive receivers of care to active, responsible, and conscious drivers of their own health, FACILITATE offers a concrete opportunity to modify the current healthcare paradigm and clinical and pharmacological research. Due to the challenges posed by differing regulations across countries, the involvement of the pharmaceutical industry is essential to create a standardized approach that ensures that the return of individual participants' data and the reuse of data for future research is incorporated from the onset of the development of clinical studies and clearly communicated while guaranteeing privacy, security, and data integrity.