The European project FACILITATE (FrAmework for ClInicaL trIal participants' daTA reutilization for a fully Transparent and Ethical Ecosystem) officially started on January 1st, 2022.
FACILITATE aims to develop an ethical, legal and regulatory framework that allows the return of clinical trial data to trial participants and other health professionals involved in their care, it also wants to create a process that allows the data collected to be reused also in future research.
The project thus aims to allow not only the “portability” of patient data, but also change the role of patients in the strategy and design of clinical trials (with many new rights and responsibilities). This innovative role has long been researched and widely discussed in recent years, also thanks to the process that led to the new EU Clinical Trials Regulation. However, it has never been fully applied yet.
What is FACILITATE?
It is a project funded under the Innovative Medicines Initiative, a public-private partnership that funds research and medical innovation with the European Horizon 2020 program and the European Federation of Pharmaceutical Industries (EFPIA).
What is the goal of this European project?
Clinical trials and trials generate a large amount of high-quality data, but only rarely are they returned to participants. Furthermore, the data are generally stored in separate repositories and cannot be used for other studies. Therefore we aim to develop a prototype of a patient-centred, data-driven process that allows for the return of clinical trial data to study participants and their reuse. The "prototype process" will be built within an approved ethical framework that complies with the GDPR, the general data protection regulation of the European Union.
FACILITATE will therefore generate technological solutions to allow the sharing and reuse of data, based first on the needs and requirements of the patients and healthcare stakeholders involved.
With the patient's consent, FACILITATE will be able to reuse and cross-reference data with that contained in other archives, including real world evidence (RWE) data acquired in multiple settings and devices.
FACILITATE offers a concrete possibility to change the current healthcare paradigm, placing patient participation at the centre of clinical research, transmitting to patients the necessary confidence to go from being a recipient of care to an active player, aware of their own health!
What role does Cittadinanzattiva play in FACILITATE?
Cittadinanzattiva is responsible for the interaction and involvement of stakeholders: patients and their associations, healthcare professionals, pharmaceutical companies, European and national institutions, civic advocacy communities, ethics committees, regulators, and principal investigators. Our job is to get them involved and contribute to the development, evaluation, and adoption of the project results. We also actively participate in communication, including digital, and dissemination activities.
Who are the stakeholders of FACILITATE?
Patients, first, to put their needs and their participation at the centre; they will follow the progress of the project from the beginning and bring their own knowledge and perspectives.
Clinicians and healthcare professionals whose perception will be assessed using structured questionnaires to define critical issues and test the effectiveness of the project activities.
Pharmaceutical companies to ensure that needs are met.
Healthcare actors on a broader spectrum, at national and European level: patient associations and European health networks, institutional actors, regulatory bodies, etc. with the aim of including their different perspectives in the development of the project.
Who are the partners in the project?
The consortium, led by the University of Modena and Reggio Emilia (UNIMORE), is made up of numerous partners (currently 27, but the number is destined to grow): patients and associations, universities, healthcare professionals, pharmaceutical companies, software designers, those who process and manage clinical trial archives, ethics experts, lawyers, data managers, data scientists.
Duration of the project:
Starting date: January 1, 2022
End date: December 31, 2025
Contact us for further information:
M addalena D’Urso,
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101034366.
The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.