“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.

FACILITATE’S main objective is the development of a new ethical, legal, and regulatory framework overcoming the current limitations and discrepancies between European Member States enabling the return of clinical trial data to study participants and other healthcare professionals involved in their care within a GDPR compliant and approved ethical framework.

FACILITATE will starts-off by defining clear and harmonized rules in a trusted ethical, legal, and regulatory ecosystem to comply with data protection regulations, regulatory requirements, and ethical standards in Europe before engaging patients as data generators.

FACILITATE will define which, when and how clinical trial data should be returned to study participants, including integration in, or interconnection with, patients’ individual health records management files or applications. 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 and ensure that the whole process is aligned with the study participants’ expectations and the authorities and ethics committees’ standards and procedures and documented in binding and/or approved standards or guidance documents.

The FACILITATE FACILITATE Consortium has been 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 embraces an innovative approach to the return of data to study participants by asking them what they need to be implemented to consider being part of 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 repository processors and controllers, ethicists, lawyers, and other active regulators.

Having obtained 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.

 

The project starts on January 1st 2022, and will last for 4 years.

For further information, please write to pmo@facilitate-project.eu

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This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101034366. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.