FACILITATE
Framework for Clinical Trial Participants’ Data Reutilization for a Fully Transparent and Ethical Ecosystem
To facilitate the process of patient access to clinical trial data and to manage re-use of data
What is FACILITATE
FACILITATE is a 4-year project launched by the Innovative Medicines Initiative (IMI) which primary aim is to enable clinical trial participants to access and make use of their personal health data gathered during studies, to allow a better shared medical decision-making with the health professionals involved in their care and to create a process that allows data to be re-used also in future research.
The Goal
FACILITATE overall goal is to develop an innovative data-sharing and re-use process within a General Data Protection Regulation (GDPR) compliant and approved ethical framework, not only to allow the access and portability of patient data but also to change the role of patients in the strategy and design of clinical trials – with many new rights and responsibilities – becoming an active component of the drug development process.
The Project
FACILITATE will first seek to create an ethical, legal, and regulatory ecosystem that provides clear rules for all stakeholders who are engaging patients and managing their very important health data. With that framework in place, FACILITATE will then aim to develop technological solutions to support the sharing and re-use of data as agreed, first, with the patients.
The Idea
FACILITATE idea is that patient study data could be available for cross-referencing with other repositories – improving upon the current situation, in which clinical data are siloed in separate repositories and unable to be used outside of the clinical trial. FACILITATE will ensure that the whole process, from the collection of data to its destruction or anonymization including its sharing and re-use, is legally and ethically compliant and aligned with the study participants’ but also hospitals’, academia, and industries’ voice.
For Whom
For Patients
to aid better shared medical decision-making
For Healthcare Professionals
to encourage clinical decision making and reduce duplication
For Regulators
to open possibilities for ethical data re-use
For EU Researchers
to permit informed workable aligned positions
For Pharma
to improve future research
For Society
to increase the trust of patients and improve oversight on clinical data re-use
Latest News
Watch the webinar – Understanding the secondary use of clinical trial data
The FACILITATE webinar Understanding the secondary use of clinical trial data, which took place on 11 December, is now available online. We invite you to follow our Stakeholders Virtual Roundtable, which explored the importance of the secondary use of clinical trial...
Opportunities and challenges of person-centric research
The European project FACILITATE has been showcased at the 10th annual Clinical Monitoring & Patient Recruitment Retention Summit on 20-21 November 2024 in Barcelona, with the topic: Advancing Patient Centric Clinical Trials: the case of IHI FACILITATE, returning...
FACILITATE step-by-step
Video Podcasts
Join us on the FACILITATE journey with our podcast series!
FACILITATE in Four Phases
Explore, assess, and align
Focuses on the needs and rights of the patients and study participants and has the purpose to gather all information needed for designing the FACILITATE platform in compliance with ethical, legal, technical, and regulatory specifications
Development
Focuses on the development of data governance models for cases where individual clinical trial data can be utilized for both healthcare decision making and future research, considering previous and ongoing EU-level activities on data governance in these fields
Piloting and Testing
Focuses on testing the FACILITATE prototype process in clinical partners centres and in others to be agreed with EFPIA
Follow Up & Evaluation
Focuses on providing recommendations concerning the new procedures needed to involve and train patients and stakeholders and provides the technical details of the FACILITATE platform to redesign clinical trials
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Latest Publications
Glossary
To go-in-depth with FACILITATE.
Enter the world of our patient-centered project!
let’s FACILITATE – Year 3 Issue 1
DOWNLOAD FULL NEWSLETTER PDF
Next Events
Latest Webinar
Watch the webinar – Understanding the secondary use of clinical trial data
The FACILITATE webinar Understanding the secondary use of clinical trial data, which took place on 11 December, is now available online. We invite you to follow our Stakeholders Virtual Roundtable, which explored the importance of the secondary use of clinical trial...
Project built on a patient-centered, data-driven, technological platform
Project Timeline
01/01/2022 – 31/12/2025
Project Partners
29 partners from 16 Member States
Total Budget
6.886.711 Euro
Project Coordinator
Università degli Studi di Modena and Reggio Emilia
Project Leader
Sanofi S.A.
Our Partners
