By Jaimy Lee
Stephanie Walker, a Black retired nurse who was diagnosed with metastatic breast cancer in 2015, has never been asked to participate in a clinical trial. But if the opportunity to do so came up, she would take it in a heartbeat.
“Give me the chance to say no after I’ve received all the information,” Walker, 63, told MarketWatch. “Let me make that informed decision.”
Black Americans like Walker are rarely asked to participate in clinical research. In fact, a survey of about 400 people she recently conducted for the Metastatic Breast Cancer Alliance found that 83% of Black patients with metastatic breast cancer said they would consider participating in a clinical trial, but 40% said no one on their care team had asked them about participating in a study.
“Nobody’s telling us about clinical trials,” Walker said. “Why is that?”
An estimated 8% of people who participated in clinical trials for new drugs approved in 2020 identify as African American or Black; roughly 3% or 4% of people who participate in cancer trials in the U.S. are Black; and only 3% of participants in studies for new cardiovascular therapies are Black.
This means that Black patients rarely get the option to try potentially groundbreaking therapies being tested in clinical research, and the treatments that become the standard of medical care in the U.S. are seldom tested in the 13% of the U.S. population that identifies as Black. And that raises questions about which patients qualify for new drugs, whether due to federal health guidelines or health insurance coverage, and how the lack of inclusion can damage trust in medicine.
“Large swaths of the U.S. population, and those that often face the greatest health challenges, are less able to benefit from these discoveries because they are not adequately represented in clinical research studies,” the authors of a congressionally mandated National Academies of Sciences, Engineering, and Medicine report wrote this spring.
Though Black mistrust of the U.S. medical system is often blamed for racial disparities in clinical trials, there are several less-cited and perhaps more influential reasons behind the lack of representation in medical research, including a lack of federal incentives, lackluster efforts by pharmaceutical companies, a clinical-trial workforce that is largely white, and physicians who have stuck to longstanding and racially biased beliefs about Black people’s unwillingness to participate in medical research.
But the COVID-19 pandemic and its disproportionate impact on people of color turned clinical trials into a well-known issue and created greater public awareness about the lack of people of color in medical research. That heightened interest, experts say, may fuel the kind of systemic change that has long been needed to ensure that clinical trials reflect the U.S. population.
“All the publicity about, and now literacy about, medical research and trials and what they mean and how the process works in terms of FDA approvals has opened a window that may not remain open for a long time,” said Dr. James Hildreth, the president and CEO of Meharry Medical College, a historically Black medical school in Nashville, Tenn. “But at least right now is a great time to continue to build on the momentum that was put into place by the response to COVID-19.”
The problem with ‘preconceived notions’
There are two buckets of issues that have to be addressed to ensure that clinical trials adequately represent any patient population, with respect to everything from race, ethnicity and gender to breastfeeding and socioeconomic status.
There’s the operational stuff, like the location of the trial sites; whether participants are paid; whether the sponsor covers the cost of parking, meals, or child care; and whether it’s possible for follow-up appointments to be done remotely using telehealth or at local clinics, rather than at the clinical-trial site. Making these options available to participants can ease concerns for people who have less-flexible work or child-care schedules and may not have extra money or time.
But what’s much more complicated is addressing why most clinical-trial participants are still white. Doing so raises uncomfortable questions about individual and institutional bias among the specialist physicians, clinical-trial investigators and pharmaceutical executives responsible for enrolling Americans in clinical research.
“Principal investigators and study staff also bring their own biases to the research enterprise,” the authors of the National Academies report wrote. “Their perceptions about a potential participant’s reliability, health literacy, language skills, and social support, among other factors, all play into whether the potential participant will be offered information on enrollment.”
When it comes to explaining why fewer Black people than white people are included in clinical trials, the go-to answer is often the infamous Tuskegee study, which purposely and without consent infected poor Black men with syphilis starting in the 1930s, withhold treatment, and never told them about their illnesses. It’s considered one of the most unethical studies ever conducted in the United States.
But medical racism still shows up in exam rooms across the country every day. Some medical students and residents falsely believe Black people feel less pain than white people, based on centuries-old and debunked thinking that there are biological differences between races, and Black patients may be less likely to comply with medical treatment plans. This means Black patients have been historically and systematically undertreated for pain compared with their white counterparts.
It also means Black patients are more likely to report that their doctors don’t believe them . For example, when tennis superstar Serena Williams had an embolism after undergoing a C-section, she had to insist on medical attention, later writing in Elle that Black maternal mortality rates would differ “if the medical establishment listened to every Black woman’s experience.”
A Pew Research Center survey from November 2021 found that Black Americans are less likely than white or Hispanic Americans to say science has had a good impact on society.
