Medical Studies Still Exclude People of Color
Lisa Caine does a little bit of everything to make science happen. She writes grants on behalf of her employers at the University of San Francisco, she coordinates a support staff, and is also in charge of finding participants for studies. One of the most recent of these was to analyze genetic risk factors for asthma in African-American children. They needed at least a few hundred patients.
She and her staff of student recruiters learned a lot along the way—the right time to call (not on Sundays or during the workday), when to stop calling someone, how to assuage the fears of kids and their parents, how to talk down someone who wants to participate but isn't eligible. They would show up to asthma clinics with a clipboard of information, a badge, and a smiling face. Everyone who agreed to participate would receive two or three phone calls to remind them.
"I think most people are open to almost anyone," Caine says. "In any research project you have to be upfront and honest in the beginning, and emphasize that our number one concern is the safety of the person or child."
More than 1,200 children were included in the study, the largest of its kind to date.
To hear Caine talk about it, recruiting minority patients for research studies seems pretty intuitive. But in reality, not nearly enough researchers are doing what Caine does. Participants in clinical trials for new treatments are frequently not as diverse as the overall population that will ultimately receive the treatment, and that has real consequences. The causes of, and symptoms for, conditions such as heart disease, cancer, and diabetes vary across lines of ethnicity and sex; if a diversity of people aren't included in the studies, we can't be sure the treatment will work for everyone, either. "If we get to study a broad range of disease, we have a much better understanding of how disease works. And we can apply that knowledge to everybody," says Sam Oh, an epidemiology researcher at the University of San Francisco who has worked with Caine.
It's a problem that has gotten a lot more attention recently, but the issue is hardly new. As more researchers seek out more diverse participants, suggestions and practices that are already working can help determine concrete, effective action, even in an uncertain political moment that could have huge implications for science.
Researchers often face an uphill battle when it comes to recruiting black study participants, understandably. Historically, experiments were conducted—many times involuntarily—on minority and other vulnerable populations (including the mentally ill and prisoners), Oh says. Even as recently as 1972, when the infamous Tuskegee study (in which 400 black men were infected with syphilis and untreated for decades) made front-page news, people defended it, says Stephen B. Thomas, a professor of health services administration at the University of Maryland and the director of the Maryland Center for Health Equity.
In the 1960s, congress passed series of regulations to make sure patients properly consent and to ensure that studies were independently reviewed before they could be conducted. That had a side effect of changing the default study population to white men. "At that time, the general understanding was homogeneity, that if you studied one population that you could generalize to everyone else," says Gary Puckrein, the president and CEO of National Minority Quality Forum.
In the 1990s, patients started to pressure government agencies and research institutions to incorporate more minorities into study populations. That's in part because patients had come to realize that diseases didn't affect everyone the same way. Women were calling for increased attention for diseases that affect only them, such as breast cancer, says Mary Woolley, president of Research!America.
Diversity among study populations slowly started to become a priority. The National Institutes of Health (NIH), which today funds about 50,000 research projects set standards for prospective grantees to recruit more diverse study populations as a result of the 1993 NIH Revitalization Act. The Food and Drug Administration (FDA) has put similar measures in place, emphasizing diversity by prioritizing drug applications tested on diverse patients. More recently other organizations have embraced diversity, including private enterprise, such as personal genomics company 23andMe and pharma giant Eli Lilly, academic institutions like University of Maryland College Park, and individual researchers.
At the same time, researchers started to understand the real and detrimental effects of homogeneous study populations. The symptoms for heart disease look different in women than they do in men. Half of Asians and 75 percent of Pacific Islanders have a genetic mutation that prevent them from properly synthesizing clopidogrel (Plavix), a blood thinner used to treat heart disease. Multiple sclerosis, a disease generally thought to affect mostly people of European descent, is driven by a different mutation when it occurs in African-Americans, Oh says. If these derivations aren't properly studied, there's no guarantee that an intervention will work.
Still, there are hurdles to getting more diverse participants. Though lots of researchers have started taking more creative tacks to recruit minorities, some stick to traditional ways. They can't, or won't, make inroads into to minority communities; some doctors don't bother approaching patients with clinical trials because they assume they won't be able to adhere to the protocol, Thomas says. Oh says that, as he trained to be a scientist, he never came across any formal instruction for cultural competency. And while NIH grantees are held to a higher standard of diversity, that organization only funds a small percentage of all clinical trials—about 6 percent of trials in 2014, according to an article from JAMA. Change is happening in science, but it hasn't reached all corners of the field yet.
There are inhibitions from the patient side, too. Granted, Americans, including minorities, are more engaged with and open to participating in medical research than ever before, according to two 2013 surveys. But wounds between scientists and black communities are not completely healed. "The history of research abuse is alive and well in many of these communities—it lives through word of mouth. And a grandmother's word of mouth is more powerful than [that] of a researcher," Thomas says. "The pattern of investigators swooping in, collecting data, and swooping out—what we call parachute or drive-by research—they know it well and are sick and tired of it. They have been poked and prodded and are still sick."
Concrete tactics are changing attitudes, of patients and of researchers. Thomas, at the University of Maryland Center of Equity, has worked hard to establish a long-term relationship with African-American communities in nearby Washington, DC and Baltimore, collaborating with researchers to give the community input on research protocols, to ensure that recruitment materials are culturally appropriate with language potential participants can embrace, to build trust and share information. The center collaborated on a program called HAIR in which public health experts teach barbers at a shop in a historically black neighborhood of Washington, DC to educate clients about screening for colorectal cancer . "Our aim is not to disarm the community—they are wise to be wary," Thomas says.
With "soft" interventions like these, it can be hard to measure progress. But Thomas knows it's being made—not because of how many participants they were able to recruit, but because of how many researchers who are shifting from a traditional, "parachute" techniques to longstanding relationships with communities, and from the number of African-American and Latino participants who are talking about their experience, demystifying the process for others in their communities. Ambitious undertakings are growing more frequent—as part of the federal precision medicine initiative, the NIH is seeking to recruit 1 million diverse patients for a study called All of Us.
Experts disagree on who bears the burden of change. But there's clearly room for researchers, pharma companies, patients, and grant organizations to do their part. This is even more important now, at the dawn of the Trump administration. Uncertainty in the political landscape could make government officials hesitant to grant research funding, or make scientists reluctant to ask for it. The Affordable Care Act (ACA) expanded Medicaid in many states, granting healthcare access to thousands more people, many of them minorities. But the recently-announced American Health Care Act, Republicans' answer to the ACA, will likely restrict their access yet again.
"Right now we have young investigators coming up for tenure trained in community-engaged research—that's new," Thomas says. "Momentum has shifted, we know this is the right thing and also the right reason. My hope is that uncertainty doesn't slow the momentum."