FrAmework for ClInicaL trIal participants daTA reutilization for a fully Transparent and Ethical ecosystem

Project Information

FACILITATE

Grant agreement ID: 101034366

DOI

10.3030/101034366

EC signature date 11 October 2021

Start date 1 January 2022

End date 30 June 2026

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 7 612 151,00

EU contribution

€ 3 260 000,00

Coordinated by

UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA
Italy

Periodic Reporting for period 3 - FACILITATE (FrAmework for ClInicaL trIal participants daTA reutilization for a fully Transparent and Ethical ecosystem)

Reporting period: 2024-01-01 to 2024-12-31

Summary of the context and overall objectives of the project

The current availability of both qualitative and quantitative health data is unprecedented in the history of mankind. Soon technology-computing, connectivity and storage capacity will enable further availability of health data exponentially in two ways: increasing computerization and quantifying self and mobile-health. Both these advances have potential issues. The increased computerization of medical processes and procedures would need to provide means to link data to information and to knowledge in a virtuous interexchange while quantifying self and mobile-health, (i.e. the possibility for each person, healthy or not, to measure their medical condition through smartphones, wearable sensors and any other digitally reducible phenotypes) by becoming the primary source of health data that would need to be reconciled with data access, usage, portability, privacy and in Europe with GDPR compliance.
The overall goal of this 4-years project is the development of a patient centred process prototype to allow the direct generation and the return of clinical trials data to study participants. By putting the study participants at the very core of their data portability and secondary use the FACILITATE project will make it easier to integrate both local and pan-European implementations considering best practices and data protection regulations.
The OVERALL OBJECTIVE is expected to be achieved through the development of a new ethical, legal, and regulatory framework overcoming the current limitations and discrepancies between European Member States to enable the return of clinical trial data to study participants and other healthcare professionals involved in their care which is further realized by building a prototype process enabling the re-use of those data for future research needs.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

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.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

As FACILITATE enters its fourth and final year, the focus will be on completing the transformation of RoIPD into a fully operational framework and finalizing the SU track through expert consensus and regulatory alignment. Next steps include:
• Piloting and refining the RoIPD prototype, ensuring usability, security, and compliance.
• Completing the Delphi study on SU and publishing the key findings to inform future data reuse strategies.
• Strengthening industry, regulatory, and patient collaborations, ensuring that RoIPD and SU frameworks are widely adopted and implemented.
• Delivering final reports and policy recommendations, setting the foundation for the future of patient-centered clinical trial data management.
The development of the Clinical Research Liaison profession and its associated master’s program will play a crucial role in ensuring that RoIPD is integrated into future clinical trials as a standard practice.
The FACILITATE Consortium remains committed to empowering clinical trial participants with control over their data, while fostering a culture of ethical, compliant, and impactful secondary use for medical research. By the end of year four, FACILITATE will not only have delivered a pioneering approach to RoIPD but will have laid the groundwork for a new era of patient engagement, regulatory clarity, and research advancement in clinical trials.

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