Lack of diversity in clinical trials has hurt patients of color. A new program aims to change that

• Sojourner Ahebee/WHYY
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  A graduate of Stanford University, Sojourner Ahebee’s writing has been published in The Atlantic, The Academy of American Poets (Poem A Day), Ploughshares and elsewhere. Sojourner is a recipient of a 2019 MacDowell Fellowship.

(Philadelphia) — A few years ago, an elderly African American patient who had just been diagnosed with rectal cancer arrived at Dr. Edith Mitchell’s office. The patient had visited and refused treatment from close to half a dozen physicians, all of whom told him he needed a permanent colostomy, a process in which an opening in the belly is made during surgery to remove a diseased part of the colon.

At the time, Mitchell, a clinical professor of medicine and oncology at Philadelphia’s Thomas Jefferson University and the director of its cancer center, was leading a clinical trial for rectal cancer therapies and connected with this patient through his primary care provider. The patient’s physician recognized that he wasn’t comfortable with the prospect of having this very invasive surgery, so he suggested that the patient get in touch with Mitchell about receiving an alternative experimental treatment through her clinical trial at Jefferson Hospital.

The treatment the patient received in the trial worked, and in the end, he didn’t need to go through with the colostomy after all, said Mitchell, who has spent her career researching and treating cancer disparities in medically underserved communities. And this positive outcome created a trust between Mitchell and the patient, who went on to encourage friends and family members battling varying forms of cancer to seek care from Mitchell and participate in future clinical trials led by her team at Jefferson.“The first thing that he said to me was … ‘[My] doctor [told me] that I might get in a clinical trial and with the results of that clinical trial, I might not need a colostomy,’” said Mitchell.

That kind of trust in health systems has been compromised or is missing altogether for many patients of color, said Mitchell, who is African American herself. And that has had a real impact on the diversity of clinical trials nationally.

According to the most recent Food and Drug Administration data on clinical trial participation, close to 80% of people taking part in the United States are white. But Black Americans, who make up 13% of the U.S. population, represent only about 7% of participants in clinical trials. Not only is that lack of proportional representation reflected across many non-white ethnic and racial groups in the country, but those same populations often carry disproportionate burdens of disease when compared to their white counterparts. For example, Black Americans have a 20% higher incidence rate for colorectal cancer than white Americans.

Drug Trial Snapshot Report … by WHYY News

“That means their risk of developing colon cancer [is higher] and [they have] the highest death rates, 40%, compared to white [Americans],” said Mitchell.

Yet drugs and new therapies being created to cure those diseases are not being tested on the vast majority of this population — which can have some serious health outcomes. It’s been documented that genetic ancestry can contribute to how well one responds to certain drugs. And, in some cases, pharmaceuticals have worked better on those with European-ancestry.

In a recent clinical trial testing a specific class of asthma drug (long-acting β2-agonists), higher rates of respiratory-related deaths, asthma-related deaths, and life-threatening events were observed among African American trial participants. In that case, African Americans represented 18% of trial participants, so the impact of the drug on the Black patient population was easily discernible.

But when the diversity of participants isn’t prioritized, it’s almost impossible to generate evidence for the safety of new treatments for specific ethnic and racial subgroups, Mitchell said. And that could have life-or-death consequences.

A $100 million program for clinical trial diversity

As the COVID-19 pandemic has laid bare deeply established health disparities in communities of color, there has been renewed attention and investment to meet the health needs of the most vulnerable populations. In 2020, the Bristol Myers Squibb Foundation and National Medical Fellowships announced that they are investing $100 million to improve diversity in clinical trials. Over the next five years, the partnership will develop a program to extend the reach of clinical trials into underserved patient populations in urban and rural U.S. communities by training and developing 250 new racially and ethnically diverse clinical investigators.

Dr. Robert Winn is the director of the Massey Cancer Center at Virginia Commonwealth University and chair of the advisory committee of Bristol Myers Squibb Foundation’s Diversity in Clinical Trials Program. Traditionally, he said, clinical trial investigators have left diverse patient populations out of their studies because of an assumption that they had higher burdens of comorbid disease such as diabetes and hypertension, and therefore would not be ideal candidates for testing drugs meant to treat a single condition.

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WHYY is the leading public media station serving the Philadelphia region, including Delaware, South Jersey and Pennsylvania. This story originally appeared on WHYY.org.