Framework to enable re-use of patient clinical data

FACILITATE (FrAmework for ClInicaL trIal participants’ daTA reutilisation for a fully Transparent and Ethical ecosystem) is a patient-driven legal framework that intends to help return clinical trial data to study participants, ready for re-use in further research or healthcare practice.

Part of a four-year project, aided by 27 partners from both EU and non-EU Member States, the framework will help develop technological solutions to support the sharing and re-use of the data. Once fully established, the framework will provide clear rules for all stakeholders who manage patient health data, state the project organisers.

Patient associations, hospitals, universities, innovative small and medium-sized enterprises (SMEs) and members of the EFPIA are all involved in the initiative.

Currently, clinical data is siloed in separate medical systems without the possibility of being used outside clinical trials. The data-driven technology platform will be able to re-use and cross-reference data with information contained in other repositories, including real world evidence (RWE) data captured across multiple settings and devices.

According to those involved, technological advancement will soon boost the availability of health data via increasing computerisation, yet data access, usage, portability and privacy will all need to work in harmony with General Data Protection Regulation (GDPR) compliance. By putting study participants at the heart of their data portability and secondary use, using their consent, FACILITATE will make it easier to integrate both local and pan-European implementations considering best practices and data protection regulations.

Goals of the FACILIATE project to enable data re-use

• Utilise technology to aid better shared medical decision-making for patients
• Encourage clinical decision-making and reduce duplication
• Open possibilities for ethical data re-use, aiding regulators
• Permit informed workable aligned positions for EU researchers
• Improve future research in the pharmaceutical industry
• Increase patient trust by overcoming oversight on clinical data re-use.

The scheme was launched earlier this year using funding from the Innovative Medicines Initiative (IMI). It was approved by the IMI Joint Undertaking (European Commission [EU] and European Federation of Pharmaceutical Industries and Associations [EFPIA] in 2021.

Professor Johanna Blom, University of Modena-Reggio Emilia (UNIMORE) vice-coordinator of FACILITATE commented: “… the purpose [of FACILIATE is] to manage the return of individual clinical trial data in a trusted legal and ethical environment. Leveraging on a patient’s needs, [the aim] is to develop a prototype process which enables the return of clinical trial data during and after the clinical trial and allows for the secondary use of that data.”