February 20, 2021
3 min read
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Andrasik reports that it has received a grant from the NIH. Del Rio reports that it has received financial support from the National Institute for Allergy and Infectious Diseases and the NIH. Silver reports funded by the Arnold P. Gold Foundation and the Binational Scientific Foundation outside of the work submitted. In the study you will find all relevant financial information from all other authors.
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A US clinical trial evaluation for vaccines found that certain racial or ethnic groups were underrepresented in both adult and child studies, while women were overrepresented, researchers reported in JAMA Network Open.
Underrepresented groups included blacks or African Americans, Native Americans or natives of Alaska, and Spanish or Latin American individuals and older adults.
An evaluation of clinical trials of vaccines in the US found that women are over-represented, while racial / ethnic minorities are under-represented in both adult and child studies.
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Laura EE Flores, BA, A graduate student at the University of Nebraska Medical Center and colleagues conducted a cross-sectional study examining data from completed U.S. vaccine studies registered on ClinicalTrials.gov July 1, 2011 through June 30, 2020. Studies representing all stages with 219,555 participants, 78.3% were randomized studies and 69.1% were for virus vaccinations.
“The goal was to provide history and context for the current differences in COVID-19 in the US and to inform future studies,” Flores told Healio.
According to the study, women made up 56% of participants in adult vaccine trials – refuting the researchers’ hypothesis that they were underrepresented. Among the studies that indicated age as a percentage, participants 65 and over made up only 12.1% of the population (95% CI, 12% -12.3%).
Laura EE Flores
Julie KK silver
The study showed that white people were over-represented (77.9%; 95% CI, 77.4% -78.4%), while black or African American people (10.6%; 95% CI, 10.2% – 11%) and Native American or Alaskan people (0.4%; 95% CI, 0.3% -0.5%) were underrepresented when compared to US census data. Asian enrollment was similar to that of census data (5.7%; 95% CI, 5.5% -6%), while Hispanic or Latin American enrollment (11.6%; 95% CI, 11.1% -12 %) was also low among the limited number of studies of adults reporting ethnicity, said Flores and colleagues.
They also found differences between pediatric studies. According to the data, the participants were black or African American (10.1%; 95% CI, 9.7% -10.6%) and Hispanic or Latin American participants (22.5%; 95% CI, 21.6% -23, 4%) strongly underrepresented.
Carlos del Rio
Michele P. Andrasik
“While we didn’t find any major gaps in representation, our study highlights the problem of chronic low-level marginalization.” Julie KK Silver, MD, Healio said, who works in the physical medicine and rehabilitation department at Harvard Medical School, Massachusetts General Hospital, and elsewhere.
“Low-level marginalization, while opposed by some people, is extremely important,” said Silver. “For example, the well-documented problem of women paying almost as much as men about 85 cents for the dollar shows deeply troubling ethical concerns and undeniable toxicity to women and their families who may be marginalized to some extent.”
Carlos del Rio, MD, Infectious Disease News Editorial Board Member and Executive Associate Dean at Emory University School of Medicine stated that while women are overrepresented in vaccine studies, they were underrepresented in other types of studies, including HIV studies, leading the FDA to approve some Limit medication.
“The work is done on different levels [to include more underrepresented populations in trials] and one field that paved the way was HIV, ”said del Rio. “Having community members on study protocol teams makes a huge difference.”
According to del Rio, the National Academies of Science, Engineering and Medicine have set up a committee to study how to improve the inclusion of women and minorities in clinical trials.
Flores proposed stricter guidelines to ensure researchers collect and report demographics of the study population. The study found that only 58.3% of the studies reported race and 34.3% reported ethnicity.
“At every step from design to implementation, there are multiple barriers to inclusion in clinical trials. In our study, we cited vendor biases, such as when medical providers only point out clinical trial opportunities to certain populations, and we addressed the legitimate medical mistrust that patients and research participants feel, ”Flores told Healio.
“As researchers, we need to make reporting on this demographic a priority when describing our studies,” said Flores. “I also believe it is a great place to start making sure our healthcare workers and clinical trial researchers look like this and are representative of the general population in order to increase diversity among clinical trial participants.”
Michele P. Andrasik, PhD, EdM, The Director of Social and Behavioral Sciences and Community Engagement and senior researcher in the Vaccines and Infectious Diseases Division at Fred Hutchinson Cancer Research Center said there was “clear evidence that proactive black, indigenous and colored (BIPOC ) are required to achieve justice. “
“We know from other studies that BIPOC patients are less likely to receive prophylactic treatment (x-rays, assessments, etc.) and that BIPOC patients are more likely to be viewed as non-compliant or non-cooperative, which can affect referral to clinical trials. Andraski said. “Given [that], more provider training or awareness of the importance of clinical trials and the participation of BIPOC individuals [are needed]. ”
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