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.
Its 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 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 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 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
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 to involve and train patients and stakeholders and provides 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 16 Member States
Università degli Studi di Modena and Reggio Emilia