At present, many groups in Europe are not adequately represented in clinical research. These underserved and underrepresented populations may include ethnicities, LGBTQ+ individuals, older adults, and those from socioeconomically disadvantaged backgrounds, among others. This lack of representation has two major consequences. First, it leads to significant gaps in our understanding of various diseases and the most effective ways to prevent and treat them across different demographic groups. Second, it means that people from these communities miss out on access to experimental health technologies, such as new medicines, vaccines, and medical devices.
Why inclusiveness and representation matter
Improving inclusiveness and representation in clinical studies will lead to more equitable healthcare access, help address existing health disparities and enhance the quality of clinical research.
However, numerous systemic barriers hamper the greater involvement of underserved and underrepresented communities in clinical studies. These barriers include geographic limitations, mistrust, poor communication, and prejudice.
The aim of READI is to foster a more holistic, integrated system around clinical studies that will support the inclusion of patients usually underserved and underrepresented, and ultimately transform the way clinical studies are carried out in Europe. The project brings together experts from various fields, such as clinical studies, public health, multistakeholder collaboration, and patient engagement as well patient representatives themselves.
READI to transform clinical trial systems, capabilities and environments
READI project coordinator Alberto Borobia of SERMAS said: “READI is designed to transform clinical trial systems, capabilities, and environments, with patients and key stakeholders working together from the design through to the delivery phase.”
One of the project’s first tasks will be to understand and characterise, at a country level, underserved and underrepresented populations in Europe and generate strategies to boost their involvement in clinical studies. Additionally, the project will co-create new methodological approaches, resources, training programs, and tools to design and conduct inclusive clinical studies.
A key outcome of the project will be the development of an open, patient-centric digital platform for clinical studies. This innovative platform will bring together in one place resources, data, and information about clinical studies, driving the evolution of more inclusive clinical research. Finally, at least four clinical studies will be used to test the effectiveness of the tools and approaches developed.
Ultimately, READI will usher in a more inclusive approach to conducting clinical trials, benefiting underserved and underrepresented groups and enhancing the quality of clinical research in Europe.
Juliette Guillot of Novartis, the project’s industry lead, concluded: "Through the collaborative efforts within the READI project, we aim to ensure that everyone across Europe, regardless of their background, has the opportunity to participate in and benefit from groundbreaking medical advancements."