In the first year, we defined work group specific tasks that resulted in essential input for the development of a new process in response to the concern about the impact of the legal and ethical existing constraints regarding return and secondary use of data. This allowed us to shift the perception of a strictly layered approach toward a flexible integrated approach that will be able to absorb ongoing developments and adaptations both at national as well as EU level regulation of ethical and legal constraints regarding clinical trial data return to patients and secondary use of data for future research.
One of FACILITATE’s missions in the first year was to define the legal and ethical constraints in place in the EU considered to be the basis from which to construct an innovative approach to CT data return and secondary use of CT data for research which is a most urgent challenge. Several main problematic issues emerged, the most pressing of which was the apparent lack of agreement about how to provide a truly integrated legal/ethical approach to consent responsible for making decisions of when, to who, what and under which conditions CT could be returned to patients. It turns out that legal and ethical views were very varied. To overcome this divergence between the legal and ethical systems that give form to CT data return as well as issues around CT data reuse for future research, WP meetings were set up to foster a productive discussion.
In its second year, FACILITATE has made significant strides in focusing on the ethical, legal, and practical aspects of returning clinical trial data to participants and facilitating its secondary use. This multidisciplinary effort, involving stakeholders sharing knowledge, competencies, resources, and risks, aims to accelerate the Return of Individual Participant Data (RoIPD) and the Secondary Use of pseudonymized data for research.
The second year emphasized enhancing the integration of biomedicine and technology, addressing the need for institutions, regulatory agencies, and clinical trial sponsors to expand their roles. This expansion is essential to improve access to innovative therapies, aligning with FACILITATE’s vision of viewing participants as continuous sources of health data, particularly in clinical trials.
In its third year, the IMI FACILITATE project has taken a decisive leap forward in enabling clinical trial participants to access and use their health-related data. The project has placed Return of Individual Participant Data (RoIPD) at the core of its efforts, ensuring that participants can receive their personal health information in a secure, ethical, and legally compliant manner. Alongside this, Secondary Use (SU) of clinical trial data has evolved into a distinct research track, designed to establish a structured and responsible framework for the reuse of medical data.
A website and an editorial strategy were created to enable ample possibility for communication that includes core knowledge regarding the project, updates, stakeholder involvement activities, presentations, and a series of webinars on outcomes. FACILITATE has extended awareness of the project through a website, social media channels, newsletters, glossary, multilingual tools, and infographics, to draw more followers in the research community so that they can benefit from the project knowledge. Specifically, special educational tools in simple language were developed to strengthen patient empowerment. Over the course of 2024, a lot of work was done in terms of communication materials: Redesign and update of the website, social media (the LinkedIn profile had almost 380 followers at the end of the year), a glossary for patients with 60 terms on CT data sharing, 3 podcasts in plain language enriched with animated infographics, 7 multilingual posters (English, Italian, German, Spanish, Serbian, French and Dutch versions), 7 multilingual brochures and flyers, 6 peer-reviewed articles and participation in several external events. Two public webinars on data return and secondary use in clinical trials have been realized, with great interest (around 400 registrations for each). A survey, involving more than 320 people, was carried out on TRUST.
