What does “community” really mean in clinical research?
It is a simple question, yet one with profound implications. As Europe works towards more inclusive and representative clinical studies, the way we understand and engage with communities becomes essential. In 2025, the READI Project took a significant step forward by developing and validating a shared definition of “community” together with an external audience.
This milestone is more than a conceptual exercise. It provides a practical foundation for building a clinical research ecosystem where every voice matters and where lived experience is recognised as essential expertise.
Why redefining community matters in clinical research
Clinical research in Europe has long faced challenges in achieving true representativeness. Many populations remain underrepresented or underserved due to barriers such as limited access to information, mistrust, or structural constraints.
As a result, clinical studies do not always reflect the range of the populations they aim to serve. This creates gaps in knowledge and limits the real-world impact of health innovations.
The READI Project is working to address these challenges by reshaping the clinical research ecosystem to ensure that all populations can access, participate in, and benefit from research.
A clear and shared definition of “community” is a critical step in this transformation.
Community in clinical research: the proposed definition
Through collaboration with stakeholders and external audiences, the READI consortium has co – developed the following definition:
“A community in clinical research is a dynamic, living, and inclusive network of individuals united by shared interests, values, and life experiences. It functions as an essential collective and a ‘library of lived experience,’ providing safety, power, and transformation, particularly for underserved and underrepresented populations. Shaped by trust and belonging, it ensures individual members feel seen and heard, and their collective voice drives impactful change towards a more democratic clinical research ecosystem.”
This definition reflects the evolving nature of communities and places people, their experiences, and their connections at the centre of clinical research.
Understanding the key concepts
To fully grasp the meaning and impact of this definition, it is helpful to explore its core elements.
Dynamic, living and inclusive
Communities are not static. They evolve over time, shaped by the people within them and the contexts they navigate. Being inclusive means actively welcoming diverse participants and ensuring that everyone has the opportunity to engage.
A “library of lived experience”
One of the most powerful ideas in this definition is the recognition of communities as a library of lived experience. This means that the real-world knowledge, stories, and insights of individuals are not just valuable, they are essential for guiding clinical research decisions.
Safety, power and transformation
Communities provide a space where individuals can feel safe to share their experiences. This safety enables empowerment and creates the conditions for meaningful transformation in how research is designed and conducted.
Trust and belonging
Trust is fundamental in clinical research. When people feel a sense of belonging, they are more likely to engage, participate, and contribute. This is especially important for underserved and underrepresented populations, who may have experienced barriers or exclusion in the past.
Why a shared definition is essential for READI?
Establishing a common understanding of “community” is not just about clarity, it is about action.
A shared definition helps ensure that:
- We speak the same language across partners, stakeholders, and countries
- We recognise underserved and underrepresented populations as integral to both existing and emerging communities
- We value lived experience as expertise, alongside scientific and clinical knowledge
This alignment is essential in a project as complex and collaborative as READI, which brings together 80 organisations across Europe and beyond to improve inclusiveness in clinical studies.
Communities as drivers of change
This definition does more than describe communities, it positions them as active drivers of systemic change.
In the READI approach, communities are not passive participants. They are:
- Contributors to research design
- Partners in decision-making
- Catalysts for improving access and participation
By embedding community perspectives into clinical research, READI aims to ensure that studies are more relevant, more inclusive, and ultimately more impactful.
This aligns with READI’s broader mission to create a clinical research ecosystem that is representative, inclusive, and accessible to all populations.
Looking ahead
As the READI Project continues, this definition will play a central role in shaping how clinical research engages with people across Europe.
It reinforces a key message:
Inclusive clinical research starts with recognising the value of communities and the expertise they bring.
By placing communities at the heart of research, READI is helping to build a future where clinical studies truly reflect the populations they serve, and where health innovations benefit everyone.
