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Final IMI project FACILITATE gets underway

The last Innovative Medicines Initiative (IMI) project to launch, FACILITATE will explore how we can return data from clinical trials to participants.

09 February 2022
A close up of a woman using the mouse pad on a laptop. Image by LDprod via Shutterstock

Clinical trials and studies generate vast amounts of high-quality data, yet it is rarely returned to the people taking part in the trial. Furthermore, the data is typically siloed in separate repositories and cannot be used for other studies.

The aim of new project FACILITATE is to develop a prototype of a patient-centered, data-driven process that would allow innovative data sharing and the re-use and return of clinical trial data to study participants. The prototype process will be built within an approved ethical framework that respects the EU’s General Data Protection Regulation (GDPR).

FACILITATE’s budget is almost EUR 7 million, coming from the EU and EFPIA companies. With a start date of 1 January 2022, it is the last Innovative Medicines Initiative (IMI) project to get underway.

The FACILITATE consortium comprises a wide range of stakeholders, including patients, healthcare professionals, software designers, processors and controllers of clinical trial repositories, ethicists, and lawyers. Together, they will build a trusted ethical, legal and regulatory ecosystem to provide clear rules for all stakeholders before engaging patients as data generators. Among other things, here the project will focus on asking study participants what they would need to feel part of a trusted ecosystem.

FACILITATE will then generate technological solutions to allow data to be shared and re-used, based on the ‘empowered willingness’ of patients. With patient consent, FACILITATE will be able to re-use and cross-reference data with data contained in other repositories including real world evidence (RWE) data captured across multiple settings and devices.

Ultimately, FACILITATE offers a concrete opportunity to modify the current healthcare paradigm, by putting patient participation at the centre of the development of health research, and give patients the confidence to shift from a passive receiver of care to an active, responsible, and aware driver of their own health.

FACILITATE is supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry.