Throughout September, the IHI READI Project joined conversations across Europe on how clinical research can become more representative, inclusive and accessible.
From discussions on how underserved and underrepresented populations are identified, to geographical access to clinical studies and the role of data standards and digital tools, READI project partners brought different dimensions of the same challenge to scientific conferences, policy discussions and stakeholder events.
These exchanges are an important part of READI’s mission to reshape the clinical studies ecosystem in Europe, enabling more people, especially underserved and underrepresented (US/UR) populations, to access, participate in and benefit from health innovations.
Understanding who is underserved and underrepresented in clinical research
On 8 September, Laetitia Chapdelaine, Adrita Kaiser and Sajid Haque from Vrije Universiteit Amsterdam (VU Amsterdam), Athena Institute, contributed to the European Association for the Study of Science and Technology conference, “More than now: exploring resilient futures.”
Their contribution explored an important question for representative clinical research: how do we understand who is underserved and who is underrepresented?
Preliminary findings presented from READI’s work showed that the two concepts are related, but not interchangeable. Underrepresentation tends to describe who is missing or insufficiently represented in research, while being underserved can draw attention to why participation gaps occur, including structural, logistical and study-design barriers. The analysis also highlighted how both concepts remain highly dependent on context.
The discussion also brought attention to the limits of the data currently available. Characteristics such as age, sex, ethnicity, disability, literacy or geographical location can help identify participation gaps, but they are not collected consistently across European data systems. Greater consistency could therefore strengthen our ability to assess representativeness, while recognising that standardised categories alone cannot capture every local or intersecting form of exclusion.
A further takeaway was that inclusiveness needs to be considered across the research lifecycle, not only at recruitment. Decisions made much earlier, including where study sites are located, can already influence who has the opportunity to participate.
Bringing clinical research closer to patients
Geographical access was also central to discussions later in the month.
On 17 September, Tina Lein Rasmussen and Nanna Herning Svensson from the University of Southern Denmark (SDU) presented READI during a meeting of the Danish Life Science Council’s Subgroup on Clinical Research.
One message resonated particularly strongly: access to relevant clinical studies should not depend on where a patient lives or the condition they have.
As healthcare increasingly moves beyond hospitals and closer to where people live, the discussion highlighted the need for clinical research infrastructure to evolve accordingly.
This perspective connects closely with READI’s wider work on geographical and structural barriers to participation. The project is working to strengthen clinical research capacity and connectivity across Europe, including in countries and regions that are currently underrepresented in the European clinical research ecosystem.
Representativeness and inclusiveness in clinical studies
On 18 September, READI Project Coordinator Alberto Borobia from SERMAS presented the project at the PtCRIN CTU Impact Day – Strengthening Investigator-Initiated Clinical Trials.
As part of the session “Clinical Trial Units as Innovation Hubs”, the presentation focused on “Inclusivity and Representativity in Clinical Trials”, bringing READI’s perspective into discussions around the role clinical research infrastructures can play in supporting more inclusive and representative studies.
This reflects one of READI’s central priorities: representativeness goes beyond the presence of different groups in a study. It considers the degree to which a study reflects the broader population it aims to serve, helping make research findings more meaningful and applicable to real-world populations.
From barriers to solutions
On 22 September, Cristina Marián from SERMAS represented READI in the International Federation of Psoriasis Associations (IFPA) Breaking Barriers Webinar Series, during the session “Until No One is Left Behind – From Barriers to Solutions: How Can We Make Clinical Trials More Inclusive?”
The discussion explored geographical barriers to clinical research and how limited availability of studies in some countries and regions can restrict opportunities to participate.
While READI focuses specifically on Europe, this challenge is also relevant within the European clinical research landscape. Part of the project’s work therefore looks at strengthening clinical research capacity in countries and regions that currently have fewer opportunities to participate in clinical studies. The discussion also considered how lessons emerging from READI could potentially inform approaches in other contexts beyond Europe.
Connecting data standards with more inclusive participation
September concluded with a discussion on how data standards and interoperability can help make clinical research more accessible and representative.
On 30 September, John Owen from CDISC presented READI at the PHUSE Real World Data Autumn Event, in a session titled “From Criteria to Connection: Enabling Diverse Participation with USDM through READI.”
The presentation highlighted how the CDISC Unified Study Definitions Model (USDM) can support more consistent, structured and machine-readable clinical study information. By improving how eligibility criteria are described and interpreted, these standards can help identify potential participation opportunities and address information-related barriers.
This perspective aligns with READI’s broader commitment to improving the accessibility and representativeness of clinical studies through collaboration, responsible data use and innovative approaches that respond to the needs of underserved and underrepresented populations.
One month, multiple perspectives on a shared challenge
September’s events approached representative and inclusive clinical research from different angles: how populations are characterised, how geographical and structural barriers affect access, how clinical research capacity can be strengthened, and how data standards and digital innovation can help connect people with research opportunities.
Together, these conversations reinforce an important principle behind READI: improving representativeness is not simply a question of recruitment numbers. It requires looking across the clinical research ecosystem, from how populations and participation gaps are understood, to study design, site capacity, accessibility, data and the tools available to patients and research teams.
By continuing to bring these perspectives into scientific, clinical and stakeholder discussions, READI is helping advance its vision of a more representative, inclusive and impactful clinical research ecosystem across Europe.
