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

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.

Preferences of people with chronic kidney disease regarding digital health interventions that promote healthy lifestyle: qualitative systematic review with meta-ethnography

“…People from rural settings (n=28, 14%) 68 70 and people with Pacific Islander; Indigenous and Hispanic heritage were under-represented ( online supplemental table S6 ). Under-representation of these groups is common in clinical research 154–156 despite the disproportionate prevalence of CKD 157–160 and numerous sociogeographical barriers to care such as shortage of health providers and distance from health facilities. 161–163 These factors reflect an urgent need to generate community-specific knowledge and develop accessible healthcare platforms to serve the needs of these disadvantaged groups.…”

Evidencing the impacts of health research: Insights from trials reported in the 2018 Australian Engagement and Impact Assessment

“…Differing Indigenous cultures are under‐served across global trials research including those in Australia, Canada, New Zealand, and the United States 26–28 . A 2021 review focused on Indigenous Australians from 2008 to 2018 found that ‘relative to population size and burden of disease, the number of trials focusing on indigenous health is low’ 29 .…”

Evidencing the impacts of health research: insights from trials reported in the 2018 Australian Engagement and Impact Assessment

“…Differing Indigenous cultures are underserved across global trials research including those in Australia, Canada, New Zealand, and the United States [26][27][28] . A 2021 review focused on Indigenous Australians from 2008-2018 found that "relative to population size and burden of disease, the number of trials focusing on indigenous health is low" 29 .…”