Challenge and Yield of Enrolling Racially and Ethnically Diverse Patient Populations in Low Event Rate Clinical Trials

Sheffet, Alice J.; Howard, George; Sam, Albert D.; Jamil, Zafar; Chiu, David; Voeks, Jenifer H.; Howard, Virginia J.; Hughes, Susan M.; Flaxman, Linda; Longbottom, Mary; Brott, Thomas G.

doi:10.1161/strokeaha.117.018063

Cited by 13 publications

(9 citation statements)

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“…According to the National Institutes of Health (NIH) [16,17], adequate enrollment and analysis plans related to racial and ethnic groups are essentially needed in clinical research, where the adequate enrollment could be determined by using the participation to prevalence ratio that is the percentage of BIPOC among trial participants divided by the percentage of BIPOC in the overall diabetes population [8]. Despite the importance of representative racial and ethnic enrollment, the current practice remained suboptimal in many randomized controlled trials (RCTs) including trials of cancer [18][19][20], stroke [21], systemic lupus erythematosus [22], cardiovascular disease [23][24][25][26][27], obesity [28], acute pain [29], coronavirus disease 2019 [30], and vaccine [31]. Likewise, one previously study reported that there were 62% and 78% of the diabetes RCTs conducted in the US and UK respectively under-enrolling the BIPOC groups [8].…”

Section: Introductionmentioning

confidence: 99%

Twenty-year trends in racial and ethnic enrollment in large diabetes randomized controlled trials

Zhang

Spall

Wang

et al. 2022

BMC Med

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Background: Lack of representativeness in Black, Indigenous, and People of Colour (BIPOC) enrollment could compromise the generalizability of study results and health equity. This study aimed to examine trends in BIPOC groups enrollment in diabetes randomized controlled trials (RCTs) and to explore the association between trial factors and high-enrollment of BIPOC groups. Methods:We systematically searched the literature on large diabetes RCTs with a sample size of ≥ 400 participants published between 2000 and 2020. We assessed temporal trends in enrollment of racial and ethnic groups in the included trials. Logistic and linear regression analyses were used to explore the relationship between trial factors and the high-enrollment defined by median enrollment rate.Results: A total of 405 RCTs were included for analyses. The median enrollment rate of BIPOC groups was 24.0%, with 6.4% for the Black group, 11.2% for Hispanic, 8.5% for Asian, and 3.0% for other BIPOC groups respectively. Over the past 20 years, the BIPOC enrollment showed an increased trend in the diabetes RCTs, ranging from 20.1 to 28.4% (P for trend = 0.041). A significant trend towards increased enrollment for Asian group was observed. We found that weekly or daily intervention frequency (OR = 0.48, 95% CI: 0.26, 0.91) and duration of intervention > 6.5 month (OR = 0.59, 95% CI: 0.37, 0.95) were significantly related to decreased odds of high-enrollment, while type 2 diabetes (OR = 1.44, 95% CI: 1.04, 1.99) was associated with high-enrollment of BIPOC groups. Conclusions:The enrollment of BIPOC was found to increase in large diabetes RCTs over the past two decades; some trial factors may be significantly associated with BIPOC enrollment. These findings may highlight the importance of enrollment of BIPOC groups and provide insights into the design and implementation of future clinical trials in diabetes.

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Section: Introductionmentioning

confidence: 99%

Twenty-year trends in racial and ethnic enrollment in large diabetes randomized controlled trials

Zhang

Spall

Wang

et al. 2022

BMC Med

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“…Our study provided a relatively unique opportunity to examine several social determinants as predictors of both consent to participate and retention as part of a prospective, longitudinal cohort study. Achieving and retaining a diverse group of participants within clinical trials has been a significant challenge reported in the literature ( 27 ). Barriers to recruitment and retention have included age, sex, socioeconomic factors, cultural factors, and practical challenges, including time and travel commitments ( 28 , 29 ).…”

Section: Discussionmentioning

confidence: 99%

Social determinants of participant recruitment and retention in a prospective cohort study of pediatric mild traumatic brain injury

et al. 2022

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BackgroundPrior studies have shown poor recruitment and retention of minoritized groups in clinical trials.ObjectiveTo examine several social determinants as predictors of consent to participate and retention as part of a prospective, longitudinal cohort study of children 8–16 with either mild traumatic brain injury (mild TBI) or orthopedic injury (OI).MethodsChildren and families were recruited during acute visits to emergency departments (ED) in two large children's hospitals in the midwestern United States for a prospective, longitudinal cohort study of children 8–16 with either mild TBI or OI.ResultsA total of 588 (mild TBI = 307; OI = 281) eligible children were approached in the ED and 315 (mild TBI = 195; OI = 120) were consented. Children who consented did not differ significantly from those who did not consent in sex or age. Consent rates were higher among Black (60.9%) and multi-racial (76.3%) children than white (45.3%) children. Among the 315 children who consented, 217 returned for a post-acute assessment (mild TBI = 143; OI = 74), a retention rate of 68.9%. Participants who were multi-racial (96.6%) or white (79.8%) were more likely to return for the post-acute visit than those who were Black (54.3%).ConclusionsRacial differences exist in both recruitment and retention of participants in a prospective, longitudinal cohort of children with mild TBI or OI. Further work is needed to understand these differences to ensure equitable participation of minoritized groups in brain injury research.

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“…Despite a policy commitment by the National Institutes of Health (NIH) and the allocation of resources to address minority recruitment by the NIH, 10 the fewer revascularizations in Black and other minority populations is reflected in their lower recruitment to the NIH-funded clinical trials. 11 It is tempting to attribute the lower rates of revascularization in minority groups to a disparity in access to care, 7 with racial/ethnic differences in revascularizations persisting after adjustment for patient and hospital characteristics in some, 6,12 but not all, 5,13 reports. Lower rates of revascularization in minority populations persist in the Veterans Health Administration System, where access to care should not be an issue.…”

Section: Clinical and Population Sciencesmentioning

confidence: 99%

“…Despite major efforts to bolster recruitment of minority patients, the percent of Blacks has remained low in the NIH trials related to asymptomatic carotid disease. 11 An important goal should be recruitment proportionate to their representation among people with the disease. These data suggest that the goals for minority recruitment for studies of asymptomatic (ie, general population) high-grade carotid stenosis should be reconsidered.…”

Section: Clinical and Population Sciencesmentioning

confidence: 99%

Race Differences in High-Grade Carotid Artery Stenosis

Lal

Meschia

Brott

et al. 2021

Stroke

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Background and Purpose: Despite a higher incidence of stroke and a more adverse cardiovascular risk factor profile in Blacks and Hispanics compared with Whites, carotid artery revascularization is performed less frequently among these subpopulations. We assessed racial differences in high-grade (≥70% diameter-reducing) carotid stenosis. Methods: Consecutive clients in a Nationwide Life Line for-Profit Service to screen for vascular disease, 2005 to 2019 were evaluated in a cross-sectional study. The prevalence of high-grade stenosis, defined by a carotid ultrasound peak systolic velocity of ≥230 cm/s, was assessed. Participants self-identified as White, Black, Hispanic, Asian, Native American, or other. Race/ethnic differences were assessed using Poisson regression. The number of individuals in the United States with high-grade stenosis was estimated by applying prevalence estimates to 2015 US Census population estimates. Results: The prevalence of high-grade carotid stenosis was estimated in 6 130 481 individuals. The prevalence of high-grade stenosis was higher with increasing age in all race-sex strata. Generally, Blacks and Hispanics had a lower prevalence of high-grade stenosis compared with Whites, while Native Americans had a higher prevalence. For example, for men aged 55 to 65, the relative risk of stenosis compared with Whites was 0.40 (95% CI, 0.29–0.55) and 0.61 (95% CI, 0.46–0.81) for Blacks and Hispanics, respectively; and 1.53 (95% CI, 1.12–2.10) for Native Americans. When these prevalence estimates were applied to the Census estimates of the US population, an estimated 327 721 individuals have high-grade stenosis, of whom 7% are Black, 7% Hispanic, and 43% women. Conclusions: Despite their having a more adverse cardiovascular risk profile, there was a lower prevalence of high-grade carotid artery stenosis for both the Black and Hispanic relative to the White clients. This lower prevalence of high-grade stenosis is a potential contributor to the lower use of carotid revascularization procedures in these minority populations.

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Challenge and Yield of Enrolling Racially and Ethnically Diverse Patient Populations in Low Event Rate Clinical Trials

Abstract: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.

Cited by 13 publications

References 50 publications

Twenty-year trends in racial and ethnic enrollment in large diabetes randomized controlled trials

Twenty-year trends in racial and ethnic enrollment in large diabetes randomized controlled trials

Social determinants of participant recruitment and retention in a prospective cohort study of pediatric mild traumatic brain injury

Race Differences in High-Grade Carotid Artery Stenosis

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