Framework for clinical trial participants data reutilization for a fully transparent and ethical ecosystem


Start Date
End Date
IMI2 - Call 23
Grant agreement number

Type of Action: 
RIA (Research and Innovation Action)

IMI Funding
3 260 000
EFPIA in kind
3 578 711
48 000
Total Cost
6 886 711


Clinical trials and studies generate vast amounts of high-quality data, yet it is rarely returned to the people taking part in the trial. Furthermore, the data is typically siloed in separate repositories and cannot be used for other studies.

The aim of FACILITATE is to develop a prototype of a patient-centered, data-driven process that would allow innovative data sharing and the re-use and return of clinical trial data to study participants. The prototype process will be built within an approved ethical framework that respects the EU’s General Data Protection Regulation (GDPR).

The consortium comprises a wide range of stakeholders, including patients, healthcare professionals, software designers, processors and controllers of clinical trial repositories, ethicists, and lawyers. Together, they will build a trusted ethical, legal and regulatory ecosystem to provide clear rules for all stakeholders before engaging patients as data generators. Among other things, here the project will focus on asking study participants what they would need to feel part of a trusted ecosystem.

FACILITATE will then generate technological solutions to allow data to be shared and re-used, based on the ‘empowered willingness’ of patients. With patient consent, FACILITATE will be able to re-use and cross-reference data with data contained in other repositories including real world evidence (RWE) data captured across multiple settings and devices.

Ultimately, FACILITATE offers a concrete opportunity to modify the current healthcare paradigm, by putting patient participation at the center of the development of health research, and give patients the confidence to shift from a passive receiver of care to an active, responsible, and aware driver of their own health.

Participants Show participants on map

EFPIA companies
  • Abbvie Inc, North Chicago, Illinois, United States
  • Almirall SA, Barcelona, Spain
  • Astrazeneca AB, Södertälje, Sweden
  • Bayer Aktiengesellschaft, Leverkusen, Germany
  • Institut De Recherches Servier, Suresnes, France
  • Mdsol Europe LTD, London, United Kingdom
  • Pfizer Limited, Sandwich, Kent , United Kingdom
  • Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
  • Takeda Pharmaceuticals International AG, Glattpark-Opfikon (Zurich), Switzerland
Universities, research organisations, public bodies, non-profit groups
  • Accademia Europea Di Bolzano, Bolzano, Italy
  • Azienda Ospedaliera Universitaria Policlinico Di Modena, Modena, Italy
  • Institut Za Medicinska Istra Ivanja, Belgrade, Serbia
  • Medizinische Universitat Graz, Graz, Austria
  • Spitalul Clinic Colentina Bucuresti, Bucuresti, Romania
  • Stichting Eupati Foundation, Utrecht, Netherlands
  • Universita Degli Studi Di Modena E Reggio Emilia, Modena, Italy
  • Vrije Universiteit Brussel, Brussel, Belgium
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Adera SAS, Pessac, France
  • Odysseus Data Services Sro, Praha, Czech Republic
  • Privanova SAS, Paris, France
  • Privredno Drustvo Zentrix Lab Drustvo SA Ogranicenom Odgovornoscu Pancevo, Pancevo, Serbia
  • St Antonius Hospital Gronau GMBH, Gronau, Germany
  • Tampereen Korkeakoulusaatio Sr, Tampere, Finland
Patient organisations
  • Associazione Cittadinanzattiva Onlus, Roma, Italy
  • Eurordis - European Organisation For Rare Diseases Association, Paris, France
  • Uniwersytet Jagiellonski, Krakow, Poland
Third parties
  • Accademia Del Paziente Esperto Eupati Aps, Roma, Italy
  • Inpeco Tpm SRL, Pula (CA), Italy
Non EFPIA companies
  • Inpeco SA, Novazzano, Switzerland
Project coordinator
Luca Pani
Universita Degli Studi Di Modena E Reggio Emilia