Framework for Clinical Trial Participants’ Data Reutilization for a Fully Transparent and Ethical Ecosystem
FACILITATE D1.1 HANDBOOK
WP1 – Project Management and Administration
VOICE OF PATIENTS
7 individual Work Packages and one supplementary
The FACILITATE project
is in 4 Phases
Please fell free to
What is Facilitate
FACILITATE project seeks to give patients access to their data to help them to become more active, responsible and aware drivers of their wellness, rather than passive receivers of care.
The Innovative Medicines Initiative (IMI) announced the launch of a new initiative that aims to help clinical trial participants access and make use of their personal health data gathered during studies. The project, dubbed FACILITATE, will seek to develop an innovative data-sharing and re-use process within a GDPR compliant and approved ethical.
FACILITATE presents a unique opportunity to help make patient access to personal data a central component of the drug development process. The project will first seek to create a trusted ethical, legal and regulatory ecosystem that provides clear rules for all stakeholders who are engaging patients as data-generators. With that framework in place, FACILITATE will then aim to develop technological solutions to support the sharing and re-use of data when consented to by patients.
The goal is to help make patient study data 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. Ideally, FACILIATE will help patients use their data to gain further insights into their health.
- For Patients
- For Healthcare Proffesionals
- For Regulators
- For EU Researchers
- For Pharma
- For Society
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.
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 and involve and train patients and stakeholders and provide the technical details of the FACILITATE platform to redesign clinical trials.
Project built on a patient-centered, data-driven, technological platform
01/01/2022 – 31/12/2025
27 partners from 17 Member States
Università degli Studi di Modena and Reggio Emilia