A Chronic Condition: Diversity in Medical Studies Is Key to Reducing Health Disparities

Since the passage of the Affordable Care Act in 2010, 16.4 million uninsured Americans have gained healthcare coverage; the largest increases are in African American and Latino communities, with 6.5 million adults gaining coverage. But the extent to which these and other minority populations are benefitting from a healthcare system informed predominantly by research on people of white European backgrounds is up for debate.

The Centers for Disease Control and Prevention’s (CDC) 2013 report “CDC Health Disparities and Inequalities” cited socioeconomic status as playing a major role in an individual’s health. That health disparities continue to be a critical issue in the U.S. comes as no surprise, then, considering the persistent income gaps between whites and minorities. As of 2015, the typical African American household had just 6 percent of the wealth of the typical white household, while the typical Latino household had just 8 percent, according to a report by public policy organization Demos.

[Above: A medical professional takes a blood sample from a Tuskegee Syphilis Study participant. (photo via Wikipedia)]

Many specific examples of health disparities exist across demographic groups. For instance, the rates of premature death (death before age 75) from stroke and coronary heart disease are higher among African Americans than whites. African Americans, Hispanics, and American Indians and Alaska Natives die from diabetes complications at a higher rate than whites. The infant mortality rate is highest for infants of African American mothers, at a rate 2.3 times that of white mothers; this rate is also higher among infants born to Puerto Rican and American Indian and Alaska Native mothers.

In addition, minorities remain underrepresented in the majority of medical studies and clinical trials, exacerbating and perhaps, in part, causing the issue. While African Americans and Hispanics make up 30 percent of the total population, they comprise just 6 percent of all participants in federally funded clinical trials — according to a report published in PLOS Medicine titled “Diversity in Clinical and Biomedical Research: A Promise Yet to Be Fulfilled.”

These statistics show that as the gap in healthcare coverage narrows, there is no similar effect on health disparities. Data reveal that minorities don’t often experience the same benefits of medical care as whites — and it’s costing all of us.

“The effects of health disparities on the U.S. healthcare system cost us about $300 billion a year. In contrast, the U.S. defense budget is about $610 billion per year, so we’re spending about half of our defense budget’s worth of money on health disparities — and everyone is affected,” says Sam Oh, PhD, co-author of the PLOS Medicine report. “There’s a significant chunk of the U.S. taxpayer base that is funding research that doesn’t directly benefit them.”

Sam Oh
Sam Oh

Oh — who is also an epidemiologist and researcher in the University of California, San Francisco’s Center for Genes, Environment, and Health — says that studying diverse populations in biomedical research not only makes for better science, but would also help reduce costs and improve the quality of care for minority patients.

Therefore, as positive as expanded healthcare coverage may be, it provides only a stopgap solution to a chronic condition. To truly reduce health disparities, Oh says, requires an emphasis on inclusion.

“[We’ve been] taking a one-size-fits-all approach to medicine, but as a country, we’ve only really studied about half of the people we’re trying to reach,” says Oh. “Everyone has some bout with illness at some point or another, and the degree to which you benefit from scientific advances is shaped in part by how well you are represented in science.”

Because of significant physiological differences across racial and ethnic groups, certain diseases and medical conditions disproportionately affect different populations, and a treatment that works for one may not work for another. These differences, along with disparities in income, can have a dire effect on the health of some populations.

Cancer, for example, disproportionately affects African Americans. Data from the National Cancer Institute reveals higher cancer incidence rates in African American men than in white men, as well as higher cancer death rates for both African American men and women than white men and women. Also, according to the American Cancer Society, more than 150,000 African Americans were diagnosed in 2009, of whom 63,000 died. No other racial or ethnic minority in the U.S. has a higher cancer death rate, yet only 2 to 4 percent of African American cancer patients have participated in cancer research studies.

Low participation in medical studies and clinical trials by minorities makes assessing the efficacy of treatments in these groups difficult.

Many obstacles may be to blame for this issue, but for African Americans in particular, researchers often cite a fear of exploitation or distrust of researchers due to past medical mistreatment as a reason for their apprehension. Arguably, the most infamous example of this is the Tuskegee Syphilis Study, which took place between 1932 and 1972; medical professionals observed the effects of syphilis in African American men without informing them they had the disease or offering treatment.

A group of test subjects from the Tuskegee Syphilis Study in Alabama in 1972 (photo via Wikipedia)
A group of test subjects from the Tuskegee Syphilis Study in Alabama in 1972 (photo via Wikipedia)

“Biomedical research has a very big black eye, historically, particularly with the Tuskegee Syphilis Study,” says Oh. “Serious moral standards were breached, as well as the African American community’s trust in biomedical research — and those scars still exist today.”

Beyond a fear of exploitation, Oh’s report cites multiple factors that can affect minorities’ ability and willingness to participate in medical studies: access to specialty centers, time and financial constraints, cultural and language barriers, lack of transportation, access to childcare services, and more.

For biomedical researchers, who are trying to stretch smaller research grants farther, recruiting and retaining minority participants is a costly endeavor. “Minority recruitment tends to be more expensive because you might need to hire translators,” Oh says, “and you might have to hire staff that is more culturally sensitive and more diverse.”

Costly Recruiting
As the largest public funder of biomedical research in the world, the National Institutes of Health (NIH) invests nearly $33 billion in medical research annually; more than 80 percent of that is awarded through 50,000 competitive grants to 300,000-plus researchers at more than 2,500 universities, medical schools, and other institutions around the world.

The NIH Revitalization Act of 1993, signed into law by President Bill Clinton, directed the NIH to prioritize the inclusion of women, minorities, and children in clinical research. Representation of these groups is now evaluated in the peer-review process for grant proposals; however, with a 22 percent decrease in federal funding for NIH since 2003, the inclusion of minorities is easier to overlook.

“Currently, the NIH allows for [the cost of recruiting minorities] to be part of the budget — and peer reviewers are not supposed to consider those costs — but because it’s getting harder and harder to get funding, grant applicants are trying to submit proposals that don’t have a huge budget,” Oh says. “One of the places where they try to cut costs is in recruitment.”

According to Oh’s research, which examined 30 years of NIH funding data, more than 95 percent of grant-funded studies focused on people of predominantly white European backgrounds.

Dr. Eliseo J. Pérez-Stable, director of the National Institute on Minority Health and Health Disparities at the NIH, says that the institution is aware of the problem and is in the process of examining possible solutions.

Dr. Eliseo J. Pérez-Stable
Dr. Eliseo J. Pérez-Stable

While the NIH does require every grant applicant to discuss the population he or she intends to target through a project — including plans for how to recruit minority participants, along with how many — holding grantees accountable is difficult. In addition, Pérez-Stable says that the inclusion of minorities is judged on an individual project basis.

“[Minority recruitment] doesn’t get weighed very much, if at all. It is a check box; did they address it — yes, no, and that’s it. In fact, if you say, ‘I live in Nebraska, and there are no minorities here, so I can’t really recruit any,’ they’ll say, ‘OK, that’s fine,’ because that project is in Nebraska,” Pérez-Stable says. “Or the investigator might say, ‘I’m going to recruit X number of minorities,’ and in the end, [he or she] may not quite meet that target. That’s just the normal research process.”

Pérez-Stable says that researchers must update the NIH annually on their progress toward recruiting and retaining minorities — information he believes is key to improving the inclusion of minorities.

Overcoming Bias
Minority representation is also low among those leading the research. Oh’s analysis of NIH data revealed that minority scientists are consistently less likely to receive NIH funding for projects.

Indeed, a 2010 analysis of the NIH peer review process — conducted by the Office of Extramural Research (OER) at NIH — revealed that only 1.1 percent of principal investigators on research project grants were African American, while 71 percent were white; 3.5 percent were Hispanic, 0.2 percent were American Indian or Alaska Native, 0.1 percent were Native Hawaiian or Pacific Islander, and 16.4 percent were Asian.

However, Pérez-Stable says that this disparity is due to fewer minorities applying for grants. “Only 2 percent of the grants that are submitted to NIH are by African American investigators, and another 2 percent or so are Latino investigators,” he says.

The OER’s analysis also determined that the percentage of white peer reviewers had very little influence on the success rates of applications from underrepresented minorities. Pérez-Stable says that this finding is the result of specific actions taken to deter bias in the grant-funding process.

“NIH asks investigators to self-identify, and most do, but then that information is separated from the grant [proposal]. It’s not shared with the reviewers, and it’s not even easy for me to access,” he says. “It’s in a separate, confidential database.”

Grant proposals receiving the highest scores from peer-review committees, along with reviewers’ assessments of them, are passed along to individual institutes within the NIH. Pérez-Stable says that his institute next considers a reviewer’s score and assessment, and then develops its own personal assessment to determine how, if at all, a project fits with the institute’s priorities. He believes this process provides an additional means of overcoming any biases exhibited by peer reviewers.

Engaging Communities
Jennifer H. Norbeck, a researcher at the NIH, is the clinical study manager on “Healthy Aging in Neighborhoods of Diversity Across the Life Span,” or HANDLS, an NIH 20-year longitudinal study focused on understanding the sources of persistent health disparities over individuals’ lifetimes.

Launched in 2004, HANDLS provides an example of how to successfully recruit and retain minority participants in medical studies. In three years, project staff was able to reach its goal of recruiting approximately 3,700 white and African American adults between the ages of 30 and 64, of varying socioeconomic backgrounds, from 13 neighborhoods in Baltimore. According to Norbeck, 59 percent of the study’s participants are African American, and she says the retention rate for all participants hovers around 80 percent.

She attributes this success to a number of factors — the most significant of which, she says, is a commitment to engaging and educating the communities they were attempting to recruit.

“When you engage a community and you explain what you want to do and why you want to do it — and that you want their help — it really makes a difference,” Norbeck says. “You don’t just want to tell them about [the study]; you want them to be part of it so they feel like they have an investment in it.”

As opposed to deferring to other scientists for advice on how to strategically recruit minorities only by addressing known barriers to their participation, Norbeck emphasizes the critical need to enter these communities. Although many barriers may be generalizable, she says that for members of minority groups, the road to participation is more complex.

“Most critical is [the need] to get out of the research institution and get to know the population being studied, the environment in which they live, work, and play; don’t assume what you have read is true for all groups,” Norbeck says. “What we found was that when we were trying to eliminate [barriers], [we] had to look at the whole picture; [we] couldn’t just look at the individual who couldn’t get there because he or she needed transportation or babysitting. It is a multifaceted problem.”

And while she admits that this hands-on approach takes a large amount of time, effort, and resources, she believes it is the best, if not the only, way to recruit minority participants.

For three years, Norbeck and her colleagues traveled in mobile units to meet with community members to learn about their concerns, answer their questions, and provide information.

During both the recruitment process and the subsequent study — participants meet with research staff every three years — researchers have maintained constant communication with participants via mailings such as birthday and holiday cards and appointment reminders. Along with providing regular updates as the study has progressed, this ongoing contact has also helped establish trust between researchers and participants. In addition, it has allowed researchers to address health issues as they have come up, such as educating about the signs and symptoms of high blood pressure after learning that many participants experience this condition.

Norbeck says that opportunities have also arisen to increase the cultural competence of the staff.

“We noticed over time that there were several folks who were transitioning, transgender, and we didn’t know a lot about [them],” she says, “so we had a panel of people who are transgender [conduct] a cultural competency session [to learn] what these folks need and what they want to be called.”

A focus on cultural competence may be key to retaining not just participants, but research staff as well. Norbeck says that awareness of personal biases and understanding of diverse populations have increased staff investment in the HANDLS study and its goals, which in turn has helped retain participants, who, she says, often remember and look forward to seeing staff members.

The benefits of taking part in the study for some participants, many of whom have very little experience with medical professionals, are incalculable, Norbeck says.

“These are people who haven’t been to the doctor in 15 years, sometimes never,” she says. “The benefit to them is they get a whole day with medical staff who will answer their questions. They can ask whatever they want; they can take as long as they want — and they value that.”

Beyond the medical benefit, HANDLS participants are provided compensation, transportation, breakfast and lunch, and access to the results of all of their lab tests conducted as part of the study.

Overall, Norbeck says that engaging communities directly can uncover new, unexpected obstacles and thus lead to better success rates.

“The whole point is that you have to be committed to identifying barriers, and not just say, ‘oh, it’s that,’ ‘no that won’t work,’ or, ‘we sent someone there, and they decided they didn’t want to participate,’” she says. “[Go] one step further and you might actually get your answer.”

Solving a Complex Issue
Further down the line is the Food and Drug Administration (FDA), which regulates and supervises prescription and over-the-counter medications, biopharmaceuticals, medical devices, and vaccines, among other items.

Charged in 2012 with examining the extent to which demographic subgroups were included in clinical trials for medical products, the FDA analyzed a cohort of 70 drug and biologic approvals from 2011. Dr. Jonca Bull, an ophthalmologist and the director of the FDA’s Office of Minority Health, says the findings revealed the FDA’s work to be “a bit uneven.”

She says her office is now working on improving data quality, raising awareness of clinical trials, and bringing greater transparency to data. However, because the FDA doesn’t conduct clinical trials in-house, its ability to affect minority participation in these studies is limited. The FDA’s efforts focus on ensuring that the populations most likely to use a drug are represented in clinical trials for that drug.

“The bottom-line question is: Are the right patients who will use the product in the trial, and are we getting data that a clinician is going to need to have confidence that when [he or she] writes a prescription, the product has been adequately characterized for safety and efficacy and … will work in this particular patient,” Bull says.

“There’s going to be some variability because we don’t believe that it’s useful to put hard numbers on this,” she adds. “There are some [diseases] that are similar in all populations, and the data is generalizable, and then there are others [that have] disproportionate impact.”

Bull recommends that researchers and commercial drug sponsors think strategically about who will be using a drug the most from the very beginning of the research process in order to recruit a more representative sample of participants.

While some believe that simply increasing biomedical research funding will lead to improvements in minority participation — because researchers will have the funds to dedicate to targeted recruitment and to spending more time in communities — Oh says this won’t solve the whole problem.

The NIH has yet to develop a specific action plan on how to address this complex issue, but Pérez-Stable says he believes there will be “movement in this area in the next couple of years.” One idea, he says, is to offer incentives to those who do a good job of recruiting minorities.

A review of the massive amount of data on this topic leads to one clear conclusion: The U.S. still has a long way to go.●

Alexandra Vollman is the editor of INSIGHT Into Diversity.