Reshaping clinical studies in Europe for a more inclusive future
Gaps in knowledge, unequal access to health and reinforced disparities in healthcare innovation are the consequences of excluding specific patients from clinical studies. These are also the challenges that the EU-funded READI(opens in new window) project has been addressing in its efforts to achieve truly inclusive clinical research in Europe.
Ambition becomes action
“One year into its journey, the READI Project has moved decisively from ambition to coordinated actions across its multi-stakeholder consortium,” reports a recent news item(opens in new window) posted on the project’s website. Since its launch in January 2025, READI’s accomplishments highlight the strategic importance of public-private collaboration in addressing the lack of inclusivity and under-representation of specific populations in clinical studies carried out across Europe. The project marked its important one-year milestone at its annual General Assembly held in Madrid at the start of 2026 with an opening address by Fátima Matute Teresa, Regional Minister of Health of the Community of Madrid.
A year’s worth of work
Using real-world data, literature reviews and expert insights, in the past year READI researchers have gained a better understanding of how well underserved and under-represented populations are currently reflected in European clinical studies. Progress has also been made on an open, patient-centred digital platform whose purpose is to improve access to study information for these populations and promote more inclusive recruitment. The READI Digital Platform(opens in new window) is being designed to ensure usability across a wide range of audiences, with use cases such as supporting hospitals to identify eligible patients through electronic health records. Efforts to strengthen clinical site capabilities are also on track. The READI team has catalogued more than 112 training resources as part of a comprehensive analysis of training needs and held its first series of online training sessions on key READI research topics, such as patient involvement and underserved/under-represented group identification and barriers. Fifty potential features of the virtual learning platform have also been mapped and prioritised based on strategic and stakeholder needs. Other key achievements include the publication of the project’s first scientific article(opens in new window) on boosting inclusivity in clinical research and the establishment of a Prioritisation Development Committee tasked to select clinical studies on which to test READI’s outputs. All project activities are underpinned by a shared ethical and regulatory framework that includes the establishment of ethics and scientific advisory boards. “In just 12 months, the consortium has built the scientific, digital, methodological and ethical foundations needed to begin improving representation into the clinical research ecosystem in Europe,” states the READI news item. As READI (Research in Europe and Diversity Inclusion) enters its second year, the focus will be on piloting the digital platform, finalising the first descriptors of underserved and under-represented populations, and proposing ways to make protocol design more representative. It will also be rolling out targeted training programmes for patients, clinical sites and research stakeholders, and starting the first use cases to test its innovations in the real world. Through its efforts, READI aims to help shape an inclusive clinical research ecosystem that makes it possible for everyone to participate – and benefit. For more information, please see: READI project website(opens in new window)
