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

Project description

Finding ways to access, use and reuse patient data

Has the EU General Data Protection Regulation (GDPR) limited Europe’s capabilities in innovative drug development? The EU-funded FACILITATE project will explore the issue. Its aim is 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. The findings will shed new light on future strategies and opportunities for medicines development and regulation.

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.

Coordinator

UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA
Net EU contribution
€ 592 348,75
Address
VIA UNIVERSITA 4
41121 Modena
Italy

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Region
Nord-Est Emilia-Romagna Modena
Activity type
Higher or Secondary Education Establishments
Links
Total cost
€ 592 348,75

Participants (31)