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 clinical trial data to patients.
Nadir Ammour, Global Lead, Sanofi, and co-leader of FACILITATE, highlighted from the very beginning of his presentation the significance of patient-centricity in research as the active, meaningful, and collaborative interaction between patients and researchers at all stages of the research process. The focus has been on the importance of research decision making guided by the input of patients as partners, recognizing their specific experiences, values, and expertise.
Starting from the consideration that people-centered research sets new expectations, beliefs, and opinions relative to returning individual clinical trial data, FACILITATE leader continued his speech listing considerations, doubts, and challenges that currently researchers list to question this new conception of centricity:
- investigators have access to the clinical trial data and are better positioned to share the data with participants upon request
- providing non-contextualized participant data may create confusion, discontinuation, and bias
- providing individual clinical trial data to study participants may impact scientific integrity
- returning individual participant clinical trial data is too complex & will impede study timelines
- individual participant clinical trial data is a topic for the future
- patients are not interested in receiving their clinical trial data
“But it is time to overcome these fears” stated Ammour “considering that 83% of participants want access to their data/results and 80% of participants want access to the overall results of the study. Now many organizations are working together to problem solve/collaborate on this topic. Among them, the FACILITATE project, which aims to develop a participant-centric approach for the systematic return of individual participant clinical trial data”.
FACILITATE definition of ‘participant-centric’ builds on contemporary discussions that emphasize the collaborative creation of a clinical trial ecosystem that integrates the perspectives of patient representatives collected throughout the development process, moving toward a model of shared decision-making where patients are an equal partner in the research project.
FACILITATE intends to deliver recommendations and proposed processes so that study participants can access their data in a manner that is both meaningful and respectful of their autonomy. Among its main goals:
- to develop guidelines for planning, processing and returning study participants data, to provide a framework that can be adopted by the clinical research community.
- to propose those guidelines to support discussions with ethical committees and data protection authorities,
- to enhance patient willingness to be involved and participate,
- to inform changes to regulation(s) If needed.
“However, these goals are not without legal challenges” added Ammour “The existing regulatory framework for clinical trials, particularly regarding informed consent and data sharing, is multifaceted and evolving. Regulations such as the General Data Protection Regulation (GDPR) and various national and international guidelines (e.g., the Declaration of Helsinki, Declaration of Taipei and CIOMS Guidelines) govern how data must be handled, emphasizing the protection of participant data and the necessity for explicit consent. Nevertheless, it is unclear about how to handle return of data”.
These regulations often present challenges, particularly in the context of data-intensive research environments where the needs for flexibility and participant engagement are increasingly recognized. Key issues include the complexity of explaining data reuse, and the implications of emerging data technologies that may outpace current consent practices.
Finally, the FACILITATE project team is consolidating outputs from other consortia initiatives and has already delivered resources publicly available and accessible on the project web site, and welcome inputs from people and experts involved in this area.
