Clinical Trials Are Not Inclusive: A New CRF-UCC Project Aims to Foster Change (Press Release)
Clinical trials shape the future of medicine, yet they frequently exclude the very populations that need representation the most. An ambitious new initiative from CRF-UCC and several partners aims to change that.
The EU-funded SENSITISE project, spearheaded by Prof. Frances Shiely, seeks to bridge the gap in clinical trials diversity. Historically, under-served groups—including ethnic minorities, the elderly, the LGBTQ+ community, rural dwellers and those with disabilities or mental health conditions—have been largely absent from research. This lack of representation means medical treatments may not be as effective for these communities. SENSITISE is set to transform the way trials are designed by providing essential education and training to researchers, ensuring fairer and more inclusive trials.
Why Representation in Clinical Trials Matters
Despite growing awareness of the need for diversity in trials, representation of under-served groups remains poor. A UCC study found that 91% of clinical trials studied failed to both record and report participant ethnicity, highlighting a significant problem. If we don’t record who are in our trials, how then will we know if the trial findings are applicable to all? Another example of this exclusion is the ethnicity of the UK’s COVID-19 Vaccine Research Registry which as of 2021, over 92% were white. Such oversights fuel health inequity and can erode trust in medical research.
“Our programme of work focuses on how to consider, who should be in your trial. Inclusivity in clinical trials is not just about fairness; it’s about ensuring that the treatments and therapies we develop work for everyone. Diverse participation helps us understand the full spectrum of how different populations respond to medical interventions, leading to safer and more effective healthcare for all” says Prof. Frances Shiely, project lead at UCC’s Health Research Board funded Clinical Research Facility and Professor of Epidemiology and Clinical Trials in the School of Public Health.
A European Partnership for Change
SENSITISE is a collaboration between UCC and leading research institutions across Europe, including the University of Aberdeen (UK), Masaryk University (Czech Republic), and ECRIN (The European Clinical Research Infrastructure Network), headquartered in France. Together, they are developing a robust educational framework to equip researchers with the skills and knowledge to ensure clinical trials accurately reflect diverse populations. On May 20th, the SENSITISE consortium will gather in Madrid for International Clinical Trials Day and contribute to the ECRIN conference, “Rethinking clinical trials: inclusivity in practice”.
SENSITISE will offer free, open-access training materials for clinical trial teams, educators, and biomedical students. These resources will be available in English, French, German and Czech, significantly broadening their reach. The initiative also includes an online module, hosted by UCC and accessible worldwide, so that research teams can integrate inclusivity training into their existing educational systems.
A Call to Action for the Research Community
“Research design and conduct is about making choices and once made, there is no way back from a bad choice. For trials, a common place to make bad choices is around who is involved in the trial. This can bake-in inequality” warns Prof. Shaun Treweek, project partner from the University of Aberdeen.
The urgency of the SENSITISE mission is clear. With over 491,000 clinical trials currently registered worldwide—more than double the number from just a few years ago—the absence of structured inclusivity training is a major oversight. SENSITISE is stepping up to fill that gap.
To learn more about the project, visit ucc.ie/en/sensitise.
Media Contact:
Prof. Frances Shiely
Director of Education, HRB CRF-UCC & Professor, School of Public Health
f.shiely@ucc.ie
About HRB CRF-UCC:
The HRB Clinical Research Facility at University College Cork (HRB CRF-UCC), co-funded by the Health Research Board and UCC’s College of Medicine and Health, supports high-quality, patient-focused research. The facility enables a wide range of studies, from academic clinical trials to regulated commercial trials, ensuring that research meets the highest international standards.
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