Pharmaceutical research must be much more inclusive and diverse to protect global health, says Kate Shaw, of Innovative Trials.
As a sector, the life sciences industry is driven to innovate. From precision medicines to genome editing and AI-powered molecules, our understanding of disease and ability to harness new and emerging technologies to advance science and drug development is always evolving. And yet, we continue to struggle with an age-old problem: clinical trials too often fail to reflect the real-world diversity of patient populations.
Why patient diversity in clinical trials matters
Patient diversity in clinical trials is a scientific, ethical and commercial necessity1. New drugs typically take 10-15 years to develop, and clinical trial data is central to bringing these medicines to market.
However, we have known for some time that trials are not always as inclusive as they could be. Older people, people with disabilities, women, people from minority ethnic communities and those from lower socioeconomic backgrounds have all historically been under-represented in clinical trials2,3,4. Recently, The Guardian newspaper revealed that only 4.4 per cent of clinical research participants in England are aged 18–24, despite Gen Z representing around 8 per cent of the population5.
Under-representation is a critical issue. Not only does it exacerbate healthcare disparities6 and deny access to innovative new treatments, it creates a scientific ‘blind spot’ where observations about safety, efficacy and optimal dosages are based on a narrow cohort of participants. This limits our understanding of a medicine and risks undermining the validity of trial data.
Considerations for greater inclusivity in clinical research
The need for more patient diversity in clinical trials is widely recognised by regulators, sponsors, research funding bodies and other organisations7,8,9,10. However, this is a complex issue. A mistrust of health systems, language barriers, a lack of awareness of clinical trial opportunities and potential bias on the part of referring clinicians and research staff can all prevent patients from enrolling11,12.
Cultural and religious considerations, financial constraints and a lack of knowledge about what clinical trials are or how to find them may also play a part. Meanwhile, study sites may not have the time or resources required to focus on diverse recruitment.
A survey of clinical research professionals earlier this year found most are not benchmarking disease demographics against enrolled populations13, making it difficult to know if companies are following through on their commitment to more inclusive trials.
When it comes to diversity, equity and inclusion in clinical research, the work must begin months or even years before the recruitment stage. The goal should always be to build trust with the communities you want to engage. This takes time but will form a secure foundation from which successful diverse patient recruitment and ongoing engagement strategies can be built.
Strategies to optimise diverse recruitment
1. Investigate the potential of AI to identify diverse communities. The rise of artificial intelligence (AI) and its ability to analyse large datasets can help determine which patients will be eligible for a clinical trial. This can be used to direct resources to locations that offer the greatest chances of success.
2. Don’t rely on digital engagement alone. Digital platforms have made it easier than ever to target and reach specific groups of people quickly and have the potential to boost recruitment efficiency14. However, an overreliance on digital risks excluding those who lack digital skills, knowledge and/or access. Digital engagement can be useful but should always be used in conjunction with other engagement activities.
3. Engage people in their communities. A key rule to building authentic relationships is to ‘fish where the fish are’. Visit people in their communities and develop partnerships with local organisations, patient advocacy groups and local leaders. Take your time to develop real relationships.
4. Work with clinicians and other healthcare professionals (HCPs). Studies consistently show that many people would be more likely to enrol into a clinical trial if it was recommended to them by their doctor. But HCPs are not always aware of every study. Implicit bias may also prevent them from referring patients15. Engage HCPs to raise awareness of open studies and consider training programmes to promote self-awareness and tackle unconscious bias.
5. Design studies in collaboration. The studies that are most effective in attracting and retaining participants are those that acknowledge and address patients’ needs. For example, the time and cost associated with regular in-person check-ups may be prohibitive for some. For others, the use of digital devices for monitoring and recording data may be too complicated. When designing studies, embrace patients as collaborators: use the relationships you build with communities to ensure the trial is designed around patients’ circumstances. Consider ways to support participants and their families and caregivers, so they don’t feel excluded.
6. Ensure patient materials are inclusive. Informed consent is a legal requirement for all clinical trials, but informed consent forms are often full of jargon, making it difficult for patients to understand. Use insights gleaned from your community engagement to ensure all materials are developed in the most appropriate language and format for the audience in question, and they answer patients’ most pertinent questions. This may mean multiple variations, which will need more time and work, but this will pay dividends when recruiting.
7. Record diversity data consistently. Establish a process for recording demographic data for each clinical trial. This should include race, age, gender, socioeconomic status and disability.
8. Consider public awareness and education campaigns. Over the last few years, there has been a growing anti-science rhetoric, particularly on some social media platforms. As an industry, we must acknowledge and tackle this issue. Greater public awareness and education about the value and importance of clinical research is vital so that more people understand why it is necessary and will be inclined to come forward and participate.
Patient diversity in clinical trials is not just an ethical nicety, it´s central to the advancement of science and medicines. All sections of society must be represented in medical research to ensure health equity and accelerate patient access to potentially life-changing treatments.
Kate specialises in patient recruitment support for clinical research and won the ‘Woman in Pharma’ award at the 2024 Pharma Industry Awards UK for her commitment to advancing science and inspiring more women into STEM.
innovativetrials.com
References
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2 Hematology & Oncology. (2024, May 3). Increasing Inclusion and Equity for Black Women in Breast Cancer Clinical Trials – Hematology & Oncology. https://www.hematologyandoncology.net/archives/may-2024/increasing-inclusion-and-equity-for-black-women-in-breast-cancer-clinical-trials/
3 Leslie J. Dickmann, Jennifer L. Schutzman, Racial and Ethnic Composition of Cancer Clinical Drug Trials: How Diverse Are We?, The Oncologist, Volume 23, Issue 2, February 2018, Pages 243–246, https://doi.org/10.1634/theoncologist.2017-0237
4 Flores LE, Frontera WR, Andrasik MP, et al. Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials. JAMA Netw Open. 2021;4(2):e2037640. doi:10.1001/jamanetworkopen.2020.37640
5 Gregory, A. (2025b, October 20). Low participation in medical trials puts millions of young people at risk. The Guardian. https://www.theguardian.com/society/2025/oct/20/low-participation-medical-trials-millions-young-people-risk
6 El-Galaly, T. C., Gaidzik, V. I., Gaman, M., Antic, D., Okosun, J., Copland, M., Sexl, V., Fielding, A. K., Doeswijk, R., Parker, H., Dreyling, M., Döhner, K., Almeida, A. M., Macintyre, E., Gribben, J. G., & Grønbæk, K. (2023). A lack of diversity, equity, and inclusion in clinical research has direct impact on patient care. HemaSphere, 7(3), e842. https://doi.org/10.1097/hs9.0000000000000842
7 Increasing the diversity of people taking part in research. (n.d.). Health Research Authority. https://www.hra.nhs.uk/planning-and-improving-research/best-practice/increasing-diversity-people-taking-part-research/
8 Association of the British Pharmaceutical Industry [ABPI]. (2025, June 25). Coalition calls for roadmap to improve inclusivity in clinical research [Press release]. Retrieved November 19, 2025, from https://www.abpi.org.uk/media/news/2025/june/coalition-calls-for-roadmap-to-improve-inclusivity-in-clinical-research/
9 National Institute for Health and Care Research [NIHR]. (n.d.). Annual Report 2024/25. National Institute for Health and Care Research (NIHR). Retrieved November 19, 2025, from https://www.nihr.ac.uk/about-us/who-we-are/reports-and-performance/annual-report-202425/inclusion
10 Incorvaia, D. (2025, February 27). As Trump targets DEI practices, 4 pharmas reaffirm commitment to diversifying clinical trials. Fierce Biotech. Retrieved November 19, 2025, from https://www.fiercebiotech.com/cro/trump-targets-dei-4-pharmas-reaffirm-commitments-diversifying-clinical-trials
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https://doi.org/10.1016/j.eclinm.2025.103513
