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

Abstract

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.

Mexican Americans agree to participate in longitudinal clinical research more than non-Hispanic whites

“…The increasing overall trend in participation we observed in this population-based observational study aligns with several recent systematic reviews on diabetes, heart failure, and cancer trials reporting increasing Latinx participation over the past decades or so [ 9 , 25 , 27 ]. However, our results contradict the widely accepted notion that participation rates declined in observational epidemiologic studies [ 20 – 24 ].…”

“…Further, although it has been widely reported that participation in observational epidemiological studies has decreased over the past several decades [ 20 – 24 ], none of these studies showed ethnic-specific time trends in participation. Other studies on historical trends in ethnic differences in participation all focused on clinical trials and had mixed findings on trends in the Latinx participation, with some reporting persistent or worsening underrepresentation, others presenting increased representation over time, and all lacking data clarifying whether the changes in representation resulted from changes in eligibility, access to clinical research, or willingness to participate, or a mixture of those [ 9 , 10 , 25 – 27 ].…”

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

“…It is acknowledged that genetic polymorphisms can affect responses to vaccines [ 34 ] and medicinal therapeutics, such as antihypertensives, heart failure medications and warfarin [ 35 ]. Interventions which have been predominantly tested in White populations may not be as effective in other ethnicities [ 20 , 36 ], and indeed a lack of representation in trials for vaccines and therapeutics fuels mistrust and vaccine hesitancy amongst minority communities [ 22 ].…”

Protected characteristics reported in pulmonary rehabilitation: a scoping review

“…As a result, the representativeness, equity and inclusivity of pulmonary rehabilitation across individual characteristics, and therefore health inequalities, are unknown. Furthermore, more evidence is needed to determine whether the intervention is equally effective across all characteristics [ 107 , 108 ]. To address this, the collection of data is vital [ 38 ].…”

“…Underrepresentation of ethnic minority groups has also been reported in cardiovascular disease [ 107 , 126 ], diabetes [ 127 ] and coronavirus disease 2019 (COVID-19) [ 128 , 129 ] research. However, if an intervention has been assessed in participants who are predominantly White British, it cannot be assumed that it will be equally effective across all other ethnicities [ 107 , 108 ]. Furthermore, reduced representation of ethnic minority groups in trials has been found to have wider implications, such as reduced trust and uptake of COVID-19 vaccines in ethnic minority groups [ 130 ], which may apply to other interventions or services, such as pulmonary rehabilitation.…”