To Save Lives, Clinical Trials Need Diversity
By Earl D. Fowlkes, Jr.
I've spent my career fighting for vulnerable patients, especially people of color. So I was ecstatic to hear about a new initiative from dozens of biotech companies.
These firms pledged to enroll more people of color in "clinical trials" -- years-long tests that show whether experimental drugs are safe and effective. Boosting diversity will tangibly improve the health of minority Americans.
White Americans are drastically overrepresented in clinical trials. Non-Hispanic whites account for 60% of the U.S. population, but roughly 86% of clinical trial participants. By contrast, Black Americans comprise 13% of the U.S. population but only 5% of clinical trial volunteers. Latino Americans account for 18% of the U.S. population but make up a measly 1% of trial participants.
Underrepresentation is a big problem for minority patients on an individual level. Clinical trial participants get lifesaving treatments years before those medicines become available to the public. That early access can -- and does -- save lives. When minorities aren't asked to participate in trials, or simply decline to do so, they lose out on these opportunities.
Underrepresentation hurts minority communities as a whole, too. That's because medications can affect various ethnic groups differently. For instance, Black Americans might experience a side effect that only rarely afflicts whites.
These disparate reactions are surprisingly common. About 20% of all new drugs approved between 2008 and 2013 caused "differences in exposure and/or response" based on patients' ethnicity.
If minorities frequently had a chance to participate in clinical trials, researchers could detect these disparate reactions early. But when trials include too few patients from various ethnic groups, it's easy to miss these disparities -- with tragic results.
Take the Breast Cancer Risk Assessment Tool, which was created to estimate a woman's breast cancer risk and developed in 1989 using data from a majority-white study group. Due to its failure to account for differences between certain demographics, the Breast Cancer Risk Assessment Tool underestimated the risk to Black women, who report higher rates of breast cancer at younger ages.
It wasn't until 2015 that the tool was explicitly modified to account for Black women's unique circumstances. It's impossible to know how many preventable deaths occurred before this adjustment was made.
Clinical trial diversity would also reduce the disproportionately high rate of chronic illnesses in minority communities. As a longtime advocate for Black, LGBT+ and HIV-positive communities, it's disturbing to see these groups underrepresented in HIV clinical trials.
Between 2002 and 2016, nearly 75% of all new HIV cases in the United States occurred in minorities. However, only about 17% of clinical trial participants were Black or Latino. In many instances, Blacks and Latinos living with HIV reported they had not even been approached about participating.
African Americans also die from cancer at higher rates than white Americans. And Hispanics are more likely to be diagnosed with late-stage cancer. Yet in clinical trials from 2008 to 2018, only 3% of oncology clinical trial participants were Black, and 6% were Hispanic.
As minority groups are more likely to be impacted by these illnesses, it's only right researchers keep them front of mind when developing new treatments. After all, they'll likely be seeking those very drugs. And yet, clinical trials continue to exclude them.
The biopharmaceutical industry's recently published principles on clinical trial diversity are a step in the right direction. Let's hope those firms to live up to these commitments.
Earl D. Fowlkes, Jr. is president and CEO of the Center for Black Equity. This piece originally ran in the International Business Times.
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