Enrollment of Black, Indigenous, and Other People of Color in Multicountry Randomized Controlled Trials of Diabetes Conducted in North America and Europe

Zhang, Jingyi; Spall, Harriette G.C. Van; Wang, Yaoyao; Thabane, Lehana; Wang, Ruoting; Li, Guowei

doi:10.2337/dc22-0261

Cited by 4 publications

(3 citation statements)

References 5 publications

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“…of trials reporting as “White”, “BAME”, “non-white”, “Other” (no. participants) References Approached for inclusion 0 0 Screened for inclusion 0 7 (60,179) [ 8 , 10 , 13 , 17 , 18 , 23 , 26 ] Eligible for inclusion 0 7 (60,179) [ 8 , 10 , 13 , 17 , 18 , 23 , 26 ] Ineligible for inclusion 0 7 (60,179) [ 8 , 10 , 13 , 17 , 18 , 23 , 26 ] Enrolled in trial 17 (52,747) [ 1 – 4 , 6 , 7 , 12 , 14 – 16 , 19 , 20 , 24 , 25 , 27 – 29 ] 11 (64,722) [ 5 , 8 – 11 , 13 ...…”

Section: Resultsmentioning

confidence: 99%

“…If the first interpretation is correct, it suggests that ethnic minority groups are more likely to be under-represented in COVID-19 trials. This continues a trend of poor recruitment from European trials when compared to North American trials, though neither have shown a temporal improvement in representation of ethnic minority participants [ 27 ]. There is also a large body of evidence which has identified previous racial and ethnic enrolment disparities in other types of medical research including trials on cancer, diabetes [ 20 , 28 ] and cardiovascular disease [ 29 ] over the last decade.…”

Section: Discussionmentioning

confidence: 99%

“…In order to combat underrepresentation, the National Institute for Health and Care Research recently developed the Innovations in Clinical Trial Design and Delivery for the Under-served (INCLUDE) framework, a tool that provides specific guidance to researchers on improving recruitment of minority groups [ 44 ]. Such an approach appears to have borne fruit in North America, where the Food and Drug Administration (FDA)-published guidance emphasises collecting racial and ethnic data in clinical trials, and appears to have improved the collection of such data [ 27 ].…”

Section: Discussionmentioning

confidence: 99%

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Ethnic minority representation in UK COVID-19 trials: systematic review and meta-analysis

Murali

Gumber

Jethwa

et al. 2023

BMC Med

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Background The COVID-19 pandemic has highlighted health disparities affecting ethnic minority communities. There is growing concern about the lack of diversity in clinical trials. This study aimed to assess the representation of ethnic groups in UK-based COVID-19 randomised controlled trials (RCTs). Methods A systematic review and meta-analysis were undertaken. A search strategy was developed for MEDLINE (Ovid) and Google Scholar (1st January 2020–4th May 2022). Prospective COVID-19 RCTs for vaccines or therapeutics that reported UK data separately with a minimum of 50 participants were eligible. Search results were independently screened, and data extracted into proforma. Percentage of ethnic groups at all trial stages was mapped against Office of National Statistics (ONS) statistics. Post hoc DerSimonian-Laird random-effects meta-analysis of percentages and a meta-regression assessing recruitment over time were conducted. Due to the nature of the review question, risk of bias was not assessed. Data analysis was conducted in Stata v17.0. A protocol was registered (PROSPERO CRD42021244185). Results In total, 5319 articles were identified; 30 studies were included, with 118,912 participants. Enrolment to trials was the only stage consistently reported (17 trials). Meta-analysis showed significant heterogeneity across studies, in relation to census-expected proportions at study enrolment. All ethnic groups, apart from Other (1.7% [95% CI 1.1–2.8%] vs ONS 1%) were represented to a lesser extent than ONS statistics, most marked in Black (1% [0.6–1.5%] vs 3.3%) and Asian (5.8% [4.4–7.6%] vs 7.5%) groups, but also apparent in White (84.8% [81.6–87.5%] vs 86%) and Mixed 1.6% [1.2–2.1%] vs 2.2%) groups. Meta-regression showed recruitment of Black participants increased over time (p = 0.009). Conclusions Asian, Black and Mixed ethnic groups are under-represented or incorrectly classified in UK COVID-19 RCTs. Reporting by ethnicity lacks consistency and transparency. Under-representation in clinical trials occurs at multiple levels and requires complex solutions, which should be considered throughout trial conduct. These findings may not apply outside of the UK setting.

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