Inclusive research: a path to equity and better outcomes
BMJ 2025; 388 doi: https://doi.org/10.1136/bmj-2024-082486 (Published 11 March 2025) Cite this as: BMJ 2025;388:e082486Linked Analysis
Designing inclusive clinical trials: how researchers can drive change to improve diversity
- Sonia S Anand, Canada research chair in ethnic diversity and cardiovascular disease13,
- Laura Arbour, professor of medical genetics45,
- Gina S Ogilvie, professor6,
- Alan T N Tita, professor7
- 1Chanchlani Research Centre, Department of Medicine, McMaster University, Hamilton, Ontario, Canada
- 2Mary Heersink School of Global Health and Social Medicine, Faculty of Health Sciences, McMaster University
- 3Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada
- 4Department of Medical Genetics, University of British Columbia, Vancouver, Canada
- 5BC Children’s Hospital Research Institute, University of British Columbia, Vancouver, Canada
- 6School of Population and Public Health, Faculty of Medicine, University of British Columbia, Vancouver, Canada
- 7Mary Heersink Institute for Global Health and Department of Obstetrics and Gynecology, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, USA
- Correspondence to: S S Anand anands{at}mcmaster.ca
The under-representation of racial and ethnic minorities in clinical trials has been a longstanding problem, with little improvement despite ongoing efforts to address it.123 A recent analysis of clinical trials registered in ClinicalTrials.gov from 2000 to 2020 shows that 80% of trial participants are white.2 The lack of ethnic diversity in clinical trials leads to fewer at-risk people from all ethnic groups benefiting from treatments that have been proved effective, thus widening health inequalities.1 Despite current pushbacks against diversity, equity and inclusion efforts, such as that seen in early 2025 by the US government,4 these efforts are crucial to improving population and individual health and ensuring the quality and integrity of healthcare.
Race is a social construct based on perceived physical differences, whereas ethnicity incorporates shared cultural traits such as language, religion, and dietary practices, and often reflects common ancestry or geographical origins, including genetic variations that may influence health outcomes.3 For example, non-white ethnic groups are disproportionately affected by type 2 diabetes compared with white populations.5 This is partly attributed to structural and social determinants of health, such as limited access to healthcare and socioeconomic differences, but people from these ethnic groups may also have higher frequency of genetic variants linked to type 2 diabetes. Despite this, these populations are severely under-represented in phase 3 drug trials, particularly those sponsored by the drug industry.5
Enhancing ethnic diversity in clinical trials requires action across the entire research pathway, from study design and recruitment to funding, regulatory approval, and dissemination of results. The key stakeholders in the structural transformations that are required include policy makers, who can set expectations …
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