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Health equity is the idea that everyone deserves the same opportunity to be as healthy as possible. To achieve health equity, we must examine and address the health disparities that exist in our society. One disparity is the lack of diversity in clinical trials, especially “Phase 3” late-stage trials, which are designed to test safety and how well a new treatment works among participants who have the condition the new medication is meant to treat.
Why the disparity?
Research has shown that minorities are more likely to experience health inequities due to social determinants of health such as economic instability, which affects a person’s ability to buy healthy food, and access to healthcare, which affects a person’s likelihood of being able to access timely and quality treatment options. In addition, African Americans and Latino communities are more likely to have underlying illnesses, such as type 2 diabetes, that may contribute to the likelihood of a COVID-19 infection, the severity of symptoms, and survival outcomes.
Although minorities are the most at risk for COVID-19, they are the least represented in clinical trials. In fact, data from a 2019 panel discussion at the BIO Conference showed that minority participation in clinical trials ranges from only 2-16% despite making up nearly 39% of the U.S. population. African Americans make up 14% of the U.S. population and account for less than 5% of clinical trial participants. Asian-Americans are 6% of the U.S. population, but make up less than 2% of all clinical trial volunteers, and for the 18% of Latino Americans, representation in clinical trials is even more scarce with only 1% of clinical trial participants identifying as Latinx.
Why is diversity needed in clinical trials?
Our world is more diverse today than ever. When clinical trials lack diversity, we all lose—especially minorities. Without a wide group of different people in clinical trials, researchers have to make hard decisions and assumptions that reflect a one-size-fits-all approach when developing new drugs.
This approach doesn’t benefit minority communities because it doesn’t take into account our genetic differences. Our age, race, ethnicity, gender, biological differences, and even geographical location can influence how illnesses or symptoms show up in our systems as well as how our bodies react to different medications, including possible side effects.
Why diversity in COVID-19 clinical trials matters
As you likely already know, COVID-19 is an infectious respiratory disease caused by a new coronavirus. This coronavirus first emerged in December 2019 and, like other viruses, it can mutate, causing new strains like the recent Omicron variant.
By January 2022, deaths related to COVID-19 are projected to hit nearly 1 million in the U.S. and more than 5 million worldwide. Unfortunately, for minorities, the impact is even greater. Minorities are disproportionately affected by COVID-19 and are more likely to die as a result of a COVID-19 infection than their white counterparts, so it’s critical that vaccines and other COVID-19 treatments meet the needs of diverse populations.
Diverse enrollment in COVID-19 clinical trials helps researchers learn more about how new medicines work in different people, as well as how to make medicines that effectively fight the Omicron variant and other emerging ones in different populations. Every COVID-19 vaccine and treatment that has been approved or emergency authorized by the U.S. Food and Drug Administration has undergone extensive, highly regulated clinical testing. When researchers have data from diverse communities, they’re in a better position to develop safer and more effective medicines to help prevent and treat COVID-19 for everyone.
“Having diverse participation in Vir’s clinical trials is a priority, and we make thoughtful choices to support that goal,” said Wendy Yeh, M.D., senior vice president, clinical development at Vir Biotechnology, a California-based company that makes medicines that are used globally to treat infectious diseases like COVID-19, hepatitis B, influenza A and HIV.
“We reach out to local organizations in diverse communities to set up trial sites that are convenient for nearby residents. Working with diverse participants helps us understand how well our potential medicines are meeting those individuals’ needs. Our approach has been especially critical during the pandemic, and when developing potential treatments for COVID-19, we have sought to include individuals from many racial and ethnic minority groups who have been disproportionately impacted by this disease.”
Diversity in COVID-19 clinical trials is a strong driver toward creating health equity. By improving diversity in COVID-19 clinical trials, we ultimately improve public health outcomes. You can potentially help improve your own health outcomes and that of your community by participating in a COVID-19 clinical trial. If you or someone you know would like to participate in a COVID-19 clinical trial, visit www.clinicaltrials.gov to enroll.
This article was sponsored by Vir Biotechnology, a company that makes potential COVID-19 treatments.
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