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Clinical Trial Participation and COVID-19: a Descriptive Analysis from the American Heart Association's Get With The
Kevin S Shah1, Adriana E Reyes-Miranda2, Steven M Bradley3
1Division of Cardiovascular Medicine, Department of Internal Medicine, University of Utah School of Medicine, 30 N. 1900 E, Room 4A100, UT, 84132, Salt Lake City, USA. Kevin.Shah@hsc.utah.edu.
Insights
Black and female patients were less likely to be enrolled in COVID-19 clinical trials. This highlights disparities in healthcare access and participation for vulnerable populations during the pandemic.
Area of Science:
- Cardiology
- Public Health
- Clinical Trials
Background:
- The COVID-19 pandemic exposed significant disparities in healthcare delivery.
- Understanding participation in clinical trials is crucial for equitable pandemic response.
Purpose of the Study:
- To investigate disparities in clinical trial enrollment among hospitalized COVID-19 patients.
- To determine if sex, race, and ethnicity influence trial participation.
Main Methods:
- Analysis of data from the American Heart Association's COVID-19 CVD Registry.
- Examined 14,397 adult patients hospitalized with COVID-19.
- Multivariable analysis to assess odds of clinical trial enrollment based on demographics.
Main Results:
- Overall, 9.5% of hospitalized COVID-19 patients were enrolled in clinical trials.
- Black patients had the lowest enrollment proportion (8%).
- Female and Black patients were significantly less likely to be enrolled compared to men and other racial groups.
Conclusions:
- Significant disparities exist in COVID-19 clinical trial enrollment based on race and sex.
- Further investigation is needed to identify and address the reasons for these participation gaps.
- Ensuring equitable access to clinical trials is vital for future public health emergencies.
Abstract:
As COVID-19 cases begin to decrease in the USA, learning from the pandemic experience will provide insights regarding disparities of care delivery. We sought to determine if specific populations hospitalized with COVID-19 are equally likely to be enrolled in clinical trials. We examined patients hospitalized with COVID-19 at centers participating in the American Heart Association's COVID-19 CVD Registry. The primary outcome was odds of enrollment in a clinical trial, according to sex, race, and ethnicity. Among 14,397 adults hospitalized with COVID-19, 9.5% (n = 1,377) were enrolled in a clinical trial. The proportion of enrolled patients was the lowest for Black patients (8%); in multivariable analysis, female and Black patients were less likely to be enrolled in a clinical trial related to COVID-19 compared to men and other racial groups, respectively. Determination of specific reasons for the disparities in trial participation related to COVID-19 in these populations should be further investigated.
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