New IMI Initiative Aims to Enable Use of Clinical Trial Data by Study Participants
FACILITATE project seeks to give patients access to their data to help them to become more active, responsible, and aware drivers of their wellness, rather than passive receivers of care
MODENA, Italy, 9th December 2021—The Innovative Medicines Initiative (IMI) today announced the launch of a new initiative that aims to help clinical trial participants access and make use of their personal health data gathered during studies.
The project, dubbed FACILITATE (FrAmework for ClInicaL trIal participants’ daTA reutilization for a fully Transparent and Ethical ecosystem), will seek to develop an innovative data-sharing and re-use process within a GDPR compliant and approved ethical framework.
FACILITATE presents a unique opportunity to help make patient access to personal data a central component of the drug development process. The project will first seek to create a trusted ethical, legal and regulatory ecosystem that provides clear rules for all stakeholders who are engaging patients as data-generators. With that framework in place, FACILITATE will then aim to develop technological solutions to support the sharing and re-use of data when consented to by patients. The goal is to help make patient study data available for cross-referencing with other repositories — improving upon the current situation, in which clinical data are siloed in separate repositories and unable to be used outside of the clinical trial. Ideally, FACILIATE will help patients use their data to gain further insights into their health.
The FACILIATE Consortium is formed by 27 partners from 17 Member States, including patient associations, hospitals, universities, subject matter experts and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Consortium partners will bring together stakeholders at every level in the decision-making chain, including patients, healthcare professionals, software designers, clinical trials repositories processors and controllers, ethicists, lawyers and other active regulators. This broad interdisciplinary team is well-positioned to tackle the ambitious challenge of helping to make patient data more accessible during future clinical trials, and the Consortium will prioritize patient input in this process.
FACILITATE is led by Università degli Studi di Modena e Reggio Emilia as Coordinator and by Sanofi, a French global biopharmaceutical company, as industry leader. The Department of Biomedical, Metabolic and Neural Sciences of the University of Modena will coordinate the project and bring expertise in project administration, legal and ethical issues and will manage the dialogue with regulatory authorities. Sanofi will contribute by leading the efforts of industrial partners, who bring expertise in clinical trials conduct, legal and data privacy.
FACILITATE is supported by a 6,9 million € budget co-funded by the European Union (represented by the European Commission) and the European pharmaceutical industry (represented by EFPIA) under the Innovative Medicines Initiative Joint Undertaking (IMI JU) programme.
FACILITATE will participate in the extended Pilot on Open Research Data of Horizon 2020. Its strategy will provide a clear framework for clinical trial data return applicable in all Member States, which is mandatory to maintain or even increase the share of clinical trials run in Europe.
See Facilitate website for more details.
About the Innovative Medicines Initiative and the European Federation of Pharmaceutical Industries and Associations
IMI is Europe’s largest public-private initiative aiming to speed up the development of better and safer medicines for patients. IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe. IMI is a joint undertaking between the European Commission and EFPIA.
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.
About The University of Modena
UNIMORE is ranked among the top comprehensive universities in Italy for its high level of research, according to the most recent assessment of the Italian Ministerial Committee for the Evaluation of Research (CIVR). The University of Modena and Reggio Emilia, brings together research groups and interdepartmental centers involved in specialized translational research emphasizing a strong collaboration between basic research, clinical research, and innovative biotechnologies while embracing the pillars of predictive, personalized, and participative health thus representing an ideal environment for the exchange of top-level expertise and scientific interests.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.