Coalition calls for roadmap to improve inclusivity in clinical research

Encouraging participation of a wide range of diverse communities in clinical research is essential to make sure that innovative medicines meet the needs of the people they are intended for, according to a new report from the Association of the British Pharmaceutical Industry (ABPI) and the Association of Medical Research Charities (AMRC).

The report, ‘Achieving inclusivity in clinical research’ [1] comes in the context of long-standing challenges in clinical trials reflecting the diversity of patients who may be eligible to take part in these studies.

A study by Ipsos in 2024 found that while 58 per cent of UK adults were willing to participate in clinical trials, this dropped to 41 per cent among ethnic minority adults. [2]

Among those invited to participate in a clinical trial, only 36 per cent of ethnic minority adults had gone on to participate, compared to 46 per cent of White adults. The survey also highlighted gender disparities within ethnic minority groups. Black, African, or Caribbean women were more likely to feel uncomfortable in healthcare environments – 19 per cent in comparison to 15 per cent for the broader ethnic minority group – and reported the highest levels of feeling unheard by trial staff (17 per cent). [2] [3]

The ABPI and AMRC held an event to understand the barriers which might prevent people from participating in trials, how to overcome these, and to understand best practice in making trials accessible to all relevant groups in society. The event brought together representatives from across the UK clinical research sector, including the pharmaceutical industry, health charities, regulatory bodies, government, and the NHS.

There were many reasons raised why diverse groups may not take part in clinical research, including practical barriers, and a lack of community engagement and trust.

To solve these, the resulting report calls for clear actions by industry, government, charities, regulators, and the NHS to encourage greater inclusivity in research. These are:

·         Create a UK-wide strategy and roadmap to drive greater diversity and inclusion in clinical trials

·         Commitments from the ABPI, AMRC and others to share and promote best practice

·         Develop an approach for measuring, collecting, and reporting clinical trial diversity

Dr Janet Valentine, Executive Director of Innovation and Research Policy at the ABPI said: “It is important that a representative population participates in clinical trials to ensure that the medicines produced work effectively across the patient group they are intended to treat.

“Prioritising diversity and inclusivity in clinical research strengthens the validity and generalisability of study findings, which means that more patients can benefit from the latest innovative medicines. We hope this report catalyses the necessary system changes that will support more eligible patients taking part in clinical research.”   

Nicola Perrin, Chief Executive of the Association of Medical Research Charities (AMRC) said: “The participation of diverse and under-served groups in research is essential to improving our understanding of how illnesses affect different people and ensure that new innovations work safely and effectively for everyone. Charities are doing fantastic things already, but as this report makes clear, collaborative and coordinated effort across the whole system is needed to drive lasting change.”

Practical barriers that prevent diverse populations from participating in clinical research include financial burden, such as travel costs, childcare expenses, and lost wages. Also, most clinical trials appointments tend to be during weekdays, making it difficult for many individuals to participate if they cannot take time off from work.

Solutions to addressing these practical barriers might include: 

•           Providing financial support in the form of stipends, reimbursements, or other financial assistance to cover transportation, childcare, and lost wages to make participation more feasible

•           Conducting trials in community health centres, local clinics, and mobile units to enable researchers to engage rural and underserved urban populations

•           Relaxing unnecessarily restrictive eligibility criteria and protocol designs, for example, offering trials in multiple languages and providing translation services to accommodate non-native speakers

•           Clear communication about logistics, remuneration and support to encourage higher levels of participation.