When it comes to the Specific Objective 1 (S01), a clearer understanding of underserved and underrepresented populations in European clinical research, was developed through a literature review and an analysis of real‑world data from clinical studies. Work also began to identify common criteria and descriptors to better characterise these populations in a consistent and harmonized way. This analysis found that clinical studies often do not reflect real populations, limiting how well results apply to the wider population and potentially biasing risk-benefit assessments. Health inequalities persist, and available demographic data usually cover only age, sex, and location, while key factors such as gender, ethnicity, race, and socioeconomic status are often missing. For SO2, technical groundwork was performed to build the minimum viable product of the digital platform supporting secure and interoperable data handling.
When it comes to the new methodological approaches and tools aimed at including US/UR populations in clinical studies (SO3), a protocol was developed to guide how participant eligibility and proportional representation should be determined, together with clearly defined inclusion goals. Work also started to identify and review existing tools and initiatives used in clinical studies, in order to select and improve those that can best support more inclusive research.
For SO4, 132 global training resources were reviewed to identify what educational materials already exist and where gaps remain. Three consortium-wide training sessions on clinical research fundamentals, patient involvement and representation were delivered (114 attendees). A READI Patient Organizations Community Hub was established to strengthen patient collaboration and engagement
For SO5, a structured mapping framework and a strategic expansion plan of the European clinical sites network, to support inclusive, multicenter trials have been created. A Clinical Trial Site Feasibility and Readiness Questionnaire will generate robust data on site readiness and capacity, providing a reproducible methodology to identify clinical sites with the potential to reach US/UR populations. As for SO6, a landscape analysis on mistrust, trust building, evaluation of trust and awareness raising was initiated. In addition, workshops were developed to define “community” in the context of clinical research and layed groundwork to build community clusters. A patient workshop was held in Ireland to identify barriers and trust enablers to clinical trials.
Contributing to SO7, the Prioritization Development Committee was established, and a methodology to drive operational implementation of clinical use cases.
The Scientific Advisory Board was also formed, composed of an EMA representative, a patient representative, and a health research and clinician.
Regarding SO8, a Data Management Plan was developed, defining data types, storage, responsibilities, and security. Ethical and Regulatory Guidelines were established to provide legal and ethical guidance to READI members. An independent Ethical Advisory Board was set up to advise the consortium on ethical and legal issues. Additionally, participatory public activities were conducted to explore barriers to participation in clinical studies, tools to overcome them, and key values in clinical research.
Finally, for the SO9, key clinical research stakeholders were identified through system mapping, and a method for effective engagement was developed, alongside a framework for assessing the long-term sustainability of each READI output.
