Clinical Trials and the Severe Lack of Racial and Ethnic Diversity
Racial diversity, inclusion, and equality is very much on the minds of Americans lately. Not surprisingly, nurses and the medical community have stepped up to speak out about racial disparities and police brutality, with many answering the calls to protest, donate, and speak out against what’s wrong. All of this being said, there is another area requiring the medical community’s attention: clinical trials.
The Problem
Clinical trials have a glaring problem – a severe lack of racial and ethnic diversity. In 2019, STAT News reported on the benefits of diversity in clinical trials, and the subsequent lack thereof, reporting, “Most clinical research includes participants who are overwhelmingly white, non-Hispanic, and, until recently, male. More than 80 percent of genome-wide association studies have been conducted among individuals of European descent. Hispanics represent 0.54 percent of those in genome-wide association studies, not more than a rounding error.”
There was also a study published in Cancer Epidemiology, Biomarkers, & Prevention, as noted by Emily Rencsok, MD in an article in June of this year that marked a concerning drop in the participation and inclusion of African American men in prostate cancer trials. In 1995, participation rates were documented as being 11.3 percent; however, in 2014 a drop to just 2.8 percent was shown. Dr.Rencsok had these important words to say on this glaring racial and ethnic diversity gap present in clinical trials, “If we leave [people of color] out [of these trials], it enforces this non-Hispanic, white-dominant scientific culture that has been prominent in the scientific community [for a very long time]. By leaving these men out, [we] essentially come up with new treatments that work well in non-Hispanic white populations. We really need to have more populations represented in clinical trials so we can get an idea of the similarities or differences [that exist] between these different groups and ensure that all patients [are] involved in clinical trials are able to receive the best possible care.”
This is not to say that there hasn’t been an attempt to address this problem In 1993, an act called the NIH Revitalization Act of 1993 was established. The passing of this act was meant to address the lack of racial and ethnic diversity in federally funded clinical research by promoting and prioritizing more equal inclusion of racial and ethnic groups, as well as women. However, despite the act being passed, the percentage of racial and ethnic diversity amongst clinical trial group participation through 2013 has stayed under two percent.
So why is there an inclusion gap with clinical trials? A Biospace article in 2018 written by biochemist Chelsea Weidman Burke sought to answer this saying, “Minorities often don’t participate in trials due to logistical challenges, financial burdens and lingering distrust from past victimization in medical experiments. The most infamous case, the Tuskegee Syphilis study, involved researchers knowingly withholding treatment from black men with syphilis, without their informed consent, to study the natural progression of the disease. Another example involves sterilizing thousands of Native American women without their consent.” Burke continued on to also explain that gaps in health insurance coverage and income barriers can play a role.
To address this racial and ethnic gap in clinical trials, the All of Us Research Program was established by the NIH. The program seeks to address diversity and inclusion problems within the health research community by inviting participants from various backgrounds throughout the U.S. As they state on their site, “Researchers will use the data to learn how our biology, lifestyle, and environment affect health. This could help them develop better treatments and ways to prevent different diseases.”
Outside of the All of Us program, there’s definitely more that can be done. It’s more important now than ever that researchers and the medical community make a concentrated effort to broaden the inclusion rates in clinical trials and actively seek to diversify programs by doing things like:
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Making clinical trial locations easily accessible to a broader portion of local communities
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Seeking to educate communities and promote awareness about the importance of clinical trials and how participation works
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Offering sponsor incentives to promote more diverse racial and ethnic inclusion among participants
Open discussion and active correction are the key to resolution.What are your thoughts on racial and ethnic diversity and inclusion in clinical trials?
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