FACILITATE

Full Title

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

Grant Agreement No.

101034366

Programme

Horizon 2020

Call Topic

H2020-JTI-IMI2-2020-23-two-stage

Duration

48 months (1 January 2021 - 31 December 2025)

Budget (Total)

€ ~7.5Μ

Budget (VUB)

€ 237.500,00

Keywords

GDPR; Patient-centred; Big data; Clinical trials; Ethics; Legal and regulatory framework

The FACILITATE project aims to find an ethical and GDPR-compliant framework for returning clinical trial data to study participants. Specifically, it will look for ways to allow patients’ data to be accessed, used and reused. The project will also show how a patient-centred data-driven approach can improve the drug development and approval process.

VUB-HALL is responsible for assessing the legal and compliance aspects, in particular the GDPR and the Clinical Trial Regulation, for the return and reuse of clinical trial data and proposing solutions for the prototype process, leading WP2 “Legal and Data Privacy framework”. Moreover, VUB-HALL is task contributor in WP1 “Project Management and Administration”, WP3 “Ethics, standardization and regulatory framework” and WP6 “Communication and dissemination”.  

UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA [IT] (Project Coordinator); VRIJE UNIVERSITEIT BRUSSEL [BE]; TAMPEREEN KORKEAKOULUSAATIO SR [FI]; STICHTING EUPATI FOUNDATION [NL]; ACCADEMIA DEL PAZIENTE ESPERTO EUPATI APS [IT]; ASS CITTADINANZATTIVA APS [IT]; PRIVANOVA SAS [FR]; ODYSSEUS DATA SERVICES SRO [CZ]; PRIVREDNO DRUSTVO ZENTRIX LAB DRUSTVO SA OGRANICENOM ODGOVORNOSCU PANCEVO [RS]; INPECO SA [CH]; INPECO TPM SRL [IT]; ADERA SAS [FR]; AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO DI MODENA [IT]; MEDIZINISCHE UNIVERSITAT GRAZ [AT]; UNIWERSYTET JAGIELLONSKI [PL]; INSTITUT ZA MEDICINSKA ISTRA IVANJA [RS]; SPITALUL CLINIC COLENTINA BUCURESTI [RO]; ST ANTONIUS HOSPITAL GRONAU GMBH [DE]; ACCADEMIA EUROPEA DI BOLZANO [IT]; EURORDIS - RARE DISEASES EUROPE [FR]; SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT [FR]; MDSOL EUROPE LTD [UK]; ABBVIE INC [US]; ASTRAZENECA AB [SE]; BAYER AKTIENGESELLSCHAFT [DE]; PFIZER LIMITED [UK]; TAKEDA PHARMACEUTICALS INTERNATIONAL AG [CH]; ALMIRALL SA [SE]; INSTITUT DE RECHERCHES SERVIER [FR]; ACCADEMIA DEL PAZIENTE ESPERTO EUPATI APS [IT]; BRISTOL-MYERS SQUIBB COMPANY CORP [US]; F. HOFFMANN-LA ROCHE AG [CH]

Project’s website

CORDIS

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