FACILITATE’s development starts and ends with stakeholders
FACILITATE will work with all stakeholder groups that could potentially be affected by the process of return of health data to study participants in order to identify their needs, shared values, and specific requirements. The objective is to build a process/system requirements that will work for all stakeholders (as defined below) and for the broader research and clinical community/ecosystem.
Ongoing Interaction/communications with the following stakeholder groups will be set up to allow co-creation of the process/system for return of clinical data and to discuss, develop and validate tools and materials in close collaboration:
1. Patients and their organisations
2. Clinicians, health-care professionals and academic research communities
3. Pharma industries
4. Civic advocacy community, investigators, regulators, HTA bodies and EU institutions.
Stakeholders’ perspective will be obtained using empirical qualitative and quantitative methods (e.g. web meetings, roundtables, dedicated surveys, events etc…)
The selected stakeholders groups, with patient representatives at the centre, will be in a prominent position to influence the development of a concrete process for returning and re-using clinical trial data and the clinical trial data management system. Stakeholders will have the opportunity to express their opinions and views on the legal and ethical requirements, and by participating in the shaping and validation of the proposed processes, tools and infrastructure solutions.