Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Feb;19(1):22-32.
doi: 10.1177/17407745211069153. Epub 2022 Jan 6.

The representation of Indigenous peoples in chronic disease clinical trials in Australia, Canada, New Zealand, and the United States

Valerie Umaefulam  1 , Tessa Kleissen  1 , Cheryl Barnabe  1
Affiliations

The representation of Indigenous peoples in chronic disease clinical trials in Australia, Canada, New Zealand, and the United States

Valerie Umaefulam et al. Clin Trials. 2022 Feb.

Abstract

Background: Indigenous peoples are overrepresented with chronic health conditions and experience suboptimal outcomes compared with non-Indigenous peoples. Genetic variations influence therapeutic responses, thus there are potential risks and harm when extrapolating evidence from the general population to Indigenous peoples. Indigenous population-specific clinical studies, and inclusion of Indigenous peoples in general population clinical trials, are perceived to be rare. Our study (1) identified and characterized Indigenous population-specific chronic disease trials and (2) identified the representation of Indigenous peoples in general population chronic disease trials conducted in Australia, Canada, New Zealand, and the United States.

Methods: For Objective 1, publicly available clinical trial registries were searched from May 2010 to May 2020 using Indigenous population-specific terms and included for data extraction if in pre-specified chronic disease. For identified trials, we extracted Indigenous population group identity and characteristics, type of intervention, and funding type. For Objective 2, a random selection of 10% of registered clinical trials was performed and the proportion of Indigenous population participants enrolled extracted.

Results: In total, 170 Indigenous population-specific chronic disease trials were identified. The clinical trials were predominantly behavioral interventions (n = 95). Among general population studies, 830 studies were randomly selected. When race was reported in studies (n = 526), Indigenous individuals were enrolled in 172 studies and constituted 5.6% of the total population enrolled in those studies.

Conclusion: Clinical trials addressing chronic disease conditions in Indigenous populations are limited. It is crucial to ensure adequate representation of Indigenous peoples in clinical trials to ensure trial data are applicable to their clinical care.

Keywords: Clinical trials; Indigenous health; Indigenous people; chronic disease; health disparities.

PubMed Disclaimer

Conflict of interest statement

Declaration of conflicting interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
PRISMA flow diagram of studies included in environmental scan.
See this image and copyright information in PMC

References

    1. Glover M, Kira A, Johnston V. et al. A systematic review of barriers and facilitators to participation in randomized controlled trials by Indigenous people from New Zealand, Australia, Canada and the United States. Glob Health Promot 2015; 22(1): 21–31. - PubMed
    1. Nazha B, Mishra M, Pentz R. et al. Enrollment of racial minorities in clinical trials: old problem assumes new urgency in the age of immunotherapy. Am Soc Clin Oncol Educ Book 2019; 39: 3–10. - PubMed
    1. Hurd K, Barnabe C. Mortality causes and outcomes in Indigenous populations of Canada, the United States, and Australia with rheumatic disease: a systematic review. Semin Arthritis Rheum 2018; 47(4): 586–592. - PubMed
    1. Hernandez LM, Blazer DG. Genes, behavior, and the social environment: moving beyond the nature/nurture debate. Washington, DC: National Academies Press, 2006, https://www.ncbi.nlm.nih.gov/books/NBK19932/ - PubMed
    1. Oh SS, Galanter J, Thakur N. et al. Diversity in clinical and biomedical research: a promise yet to be fulfilled. PLoS Med 2015; 12(12): e1001918. - PMC - PubMed

Publication types

Grants and funding

LinkOut - more resources