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FACILITATE

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Cerrado

FrAmework for ClInicaL trIal participants daTA reutilization for a fully Transpa...

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

31/12/2025

UNIMORE

8M€

Presupuesto del proyecto: 8M€

Líder del proyecto

UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMI... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Ver 30 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2021-10-11

IMI2-2020-23-01: Returning Clinical Trial Data to st...

I+D

Cerrada hace 4 años

0% 43% 100%

Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

30 Participantes

UNIMORE

592.35K€ | Lider

MDSOL EUROPE LTD

200.00K€ | Participante

UNIWERSYTET JAGIELLONSKI

77.75K€ | Participante

BAYER AKTIENGESELLSCHAFT

350.00K€ | Participante

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Duración del proyecto: 50 meses Fecha Inicio: 2021-10-11
Fecha Fin: 2025-12-31

Líder del proyecto

UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMI... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 8M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto 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.

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