First published in the November 2025 edition of DIA’s Global Forum, this piece by Jane Morrin O’Rourke, Naho Yamazaki, Becky Purvis (HRA) and Mandy Budwal-Jagait, Jason Wakelin-Smith and Kingyin Lee (MHRA) dives into one of the UK’s most urgent research challenges: how to make clinical trials genuinely inclusive. The authors explore why under-representation continues to skew evidence, the barriers that keep many communities out, and how new HRA–MHRA guidance on Inclusion and Diversity Plans aims to hard-wire equity into trial design. They also chart the early lessons from a national pilot and the wider push to embed a culture of inclusion across the UK’s research ecosystem.
Everybody should benefit from the advancements in care and treatments made through research with no one, or no group, unfairly excluded. This can only happen if we understand how interventions work for different groups of people. To gather this evidence, research must be representative of the people who stand to benefit from it.
However, due to barriers that inhibit participation, many groups and communities in society are not benefiting from the findings of research. This in turn impacts their access to high-quality healthcare.
In the UK, the Health Research Authority (HRA) and Medicines & Healthcare products Regulatory Agency (MHRA) are well-placed to set expectations, and support researchers to meet expectations, for the design and planning of clinical trials and clinical investigations that support diversity of participants. This article illustrates the current work in this area.
The Importance of Diversity
Including a range of people in research, which is representative of the broader population, is crucial in providing an understanding of the safety and effectiveness of medicines and devices, as well as information about an illness or condition across different groups of people.
Research that is designed to include those who may be impacted by the findings helps to:
- Improve our understanding of a disease and the medicinal product or intervention under investigation;
- Ensure that the data generated reflects the diversity of the population expected to use the medicinal product or intervention; and
- Potentially identify effects on safety or efficacy outcomes that may be associated with or occur more or less frequently within these populations.
Health inequalities have a significant effect on individuals, communities, and society, impacting health outcomes and life expectancy, as well as costs to the health system and wider economy. Addressing health inequalities is a key priority as set out in the UK government’s 10 Year Health Plan. The UK can play an important role in reducing health inequalities by embedding a principle of inclusion in research.
There is strong public support for this. An online survey of more than 5,000 adults across the UK showed that 88% think it’s important to include a diverse mix of participants in research. The majority of people still hold this view, even if ensuring diversity means the research costs more money (70%) or takes more time (74%).
It is not only communities and/or societies who benefit from health professionals using the findings from representative research. This also benefits life science companies. Findings that apply to a larger proportion of the population are likely to support greater uptake of their products. Inclusive research can help patients and their healthcare providers discuss and make informed decisions on the most suitable treatment option available to them.
