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

Objective

FACILITATE is a project built on a patient-centered, data-driven, technological platform where an innovative data sharing and re-use process allows the returning of clinical trial data to study participants within a GDPR compliant and approved ethical framework. FACILITATE starts-off by providing clear rules in a trusted ethical, legal and regulatory ecosystem before engaging patients as data generators. This avoids the current situation where clinical data are siloed in separate repositories without any possibility to be used beyond their original single-sided purpose. FACILITATE will provide the technological solutions to comply with GDPR in medical research by building on the empowered stakeholders' willingness to share and re-use their data. The FACILITATE Consortium was constituted by drawing from a broad range of capacities to tackle the ambitious challenges related to future clinical trials, such as preventive, long-term and real-world evidence trials. The Consortium took an innovative approach to the data return to study participants by asking them what they needed to be implemented to feel in a trusted ecosystem. This required all Consortium participants to leverage on their existing networks to bring together stakeholders at all levels in the decision-making chain, including patients, healthcare professionals, software designers, clinical trials repositories processors and controllers, ethicists, lawyers and other active regulators. Having obtained a consent on the data portability FACILITATE will re-use and cross-reference them with those contained in other repositories including RWE data captured across multiple settings and devices. FACILITATE will last 4 years and will participate in the extended Pilot on Open Research Data of Horizon 2020. Its strategy represents a unique and innovative opportunity for medicines drug development and regulation to better understand the clinics of diseases, and to evaluate the effectiveness of products in the healthcare system.

Call for proposal

H2020-JTI-IMI2-2020-23-two-stage
See other projects for this call

Coordinator

UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA
Address
Via Universita 4
41121 Modena
Italy
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 592 348,75

Participants (26)

VRIJE UNIVERSITEIT BRUSSEL
Belgium
EU contribution
€ 237 500
Address
Pleinlaan 2
1050 Brussel
Activity type
Higher or Secondary Education Establishments
TAMPEREEN KORKEAKOULUSAATIO SR
Finland
EU contribution
€ 215 250
Address
Kalevantie 4
33100 Tampere
Activity type
Higher or Secondary Education Establishments
STICHTING EUPATI FOUNDATION
Netherlands
EU contribution
€ 82 125
Address
Daltonlaan 600
3584 BK Utrecht
Activity type
Other
ASSOCIAZIONE CITTADINANZATTIVA ONLUS
Italy
EU contribution
€ 175 225
Address
Via Cereate 6
00183 Roma
Activity type
Other
PRIVANOVA SAS
France
EU contribution
€ 290 000
Address
34 Avenue Des Champs-elysées
75008 Paris
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ODYSSEUS DATA SERVICES SRO
Czechia
EU contribution
€ 381 625
Address
Pobrezni 249/46 Karlin
186 00 Praha
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
PRIVREDNO DRUSTVO ZENTRIX LAB DRUSTVO SA OGRANICENOM ODGOVORNOSCU PANCEVO
Serbia
EU contribution
€ 268 375
Address
Aksentija Maksimovica 3
26000 Pancevo
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
INPECO SA
Switzerland
EU contribution
€ 0
Address
Via Torraccia 26
6883 Novazzano
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ADERA SAS
France
EU contribution
€ 91 500
Address
Av Du Docteur Albert Schweitzer 162
33600 Pessac
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO DI MODENA
Italy
EU contribution
€ 72 500
Address
Via Del Pozzo 71
41124 Modena
Activity type
Research Organisations
MEDIZINISCHE UNIVERSITAT GRAZ
Austria
EU contribution
€ 134 625
Address
Auenbruggerplatz 2
8036 Graz
Activity type
Higher or Secondary Education Establishments
UNIWERSYTET JAGIELLONSKI
Poland
EU contribution
€ 77 750
Address
Ul. Golebia 24
31007 Krakow
Activity type
Higher or Secondary Education Establishments
INSTITUT ZA MEDICINSKA ISTRA IVANJA
Serbia
EU contribution
€ 83 062,50
Address
Dr Subotica 4 Prizemlje
11129 Belgrade
Activity type
Research Organisations
SPITALUL CLINIC COLENTINA BUCURESTI
Romania
EU contribution
€ 54 675
Address
Soseaua Stefan Cel Mare 19-21 Sector 2
020125 Bucuresti
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
ST ANTONIUS HOSPITAL GRONAU GMBH
Germany
EU contribution
€ 87 938,75
Address
Mollenweg 22
48599 Gronau
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ACCADEMIA EUROPEA DI BOLZANO
Italy
EU contribution
€ 275 250
Address
Viale Druso 1
39100 Bolzano
Activity type
Research Organisations
EURORDIS - EUROPEAN ORGANISATION FOR RARE DISEASES ASSOCIATION
France
EU contribution
€ 140 250
Address
Rue Didot 96
75014 Paris
Activity type
Other
SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT
France
EU contribution
€ 0
Address
Pierre Brossolette 1
91380 Chilly Mazarin
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
MDSOL EUROPE LTD
United Kingdom
EU contribution
€ 0
Address
12 Hammersmith Grove
W6 7AP London
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ABBVIE INC
United States
EU contribution
€ 0
Address
North Waukegan Road 1
60064 North Chicago Il
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ASTRAZENECA AB
Sweden
EU contribution
€ 0
Address
Vastra Maelarhamnen
151 85 Sodertaelje
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BAYER AKTIENGESELLSCHAFT
Germany
EU contribution
€ 0
Address
Kaiser-wilhelm-allee 1
51373 Leverkusen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
PFIZER LIMITED
United Kingdom
EU contribution
€ 0
Address
Ramsgate Road
CT13 9NJ Sandwich
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
TAKEDA PHARMACEUTICALS INTERNATIONAL AG
Switzerland
EU contribution
€ 0
Address
Thurgauerstrasse 130
8152 Glattpark
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ALMIRALL SA
Spain
EU contribution
€ 0
Address
General Mitre 151
08022 Barcelona
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
INSTITUT DE RECHERCHES SERVIER
France
EU contribution
€ 0
Address
3 Rue De La Republique
92150 Suresnes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)