FACILITATE

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

Summary

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 centre 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.

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Participants

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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

Participants
NameIHI funding in €
Accademia Europea Di Bolzano275 250
Adera SAS91 500
Associazione Cittadinanzattiva Onlus175 225
Azienda Ospedaliera Universitaria Policlinico Di Modena72 500
Eurordis - European Organisation For Rare Diseases Association140 250
Institut Za Medicinska Istra Ivanja83 063
Medizinische Universitat Graz134 625
Odysseus Data Services Sro381 625
Privanova SAS290 000
Privredno Drustvo Zentrix Lab Drustvo SA Ogranicenom Odgovornoscu Pancevo268 375
Spitalul Clinic Colentina Bucuresti54 675
St Antonius Hospital Gronau GMBH87 939
Stichting Eupati Foundation56 138
Tampereen Korkeakoulusaatio Sr215 250
Universita Degli Studi Di Modena E Reggio Emilia592 349
Uniwersytet Jagiellonski77 750
Vrije Universiteit Brussel237 500
 
Third parties
NameFunding in €
Accademia Del Paziente Esperto Eupati Aps25 988
 
Total Cost3 260 002