Improving Racial Diversity and Equity in Clinical TrialsImproving Racial Diversity and Equity in Clinical Trials https://pediatricsnationwide.org/wp-content/uploads/2022/04/Page-26-1024x511.jpg 1024 511 Jeb Phillips Jeb Phillips https://pediatricsnationwide.org/wp-content/uploads/2021/03/Jeb-Phillips.jpg
- April 20, 2022
- Jeb Phillips
There is now broad consensus across medicine that clinical trials must be more representative of minority populations. How can that be achieved?
Last year, a group of Nationwide Children’s Hospital neonatologists published an unusually pointed critique of racial and ethnic representation in neonatal clinical trials in the Journal of Perinatology.
They wrote that the lack of urgency in addressing crises such as the inequities in health outcomes for Black birthing people and infants characterized “an insidious apathy among researchers and clinicians that spans centuries in this country.” They called out how the “inability to acknowledge and account for how structural racism affects social determinants of health directly impedes study design, recruitment, analysis and interpretation.”
“I am frustrated with my field,” says lead author and neonatologist Valencia P. Walker, MD, who also serves as associate chief diversity and health equity officer at Nationwide Children’s.
Dr. Walker is not the only one, and neonatology is not the only field. This wasn’t even the only publication of its kind that came from Nationwide Children’s authors over the last year. At least three other commentaries addressing increasing racial and ethnic diversity in pharmaceutical trials, critical care research and the human genome reference.
While there have been criticisms for decades about inequitable representation in clinical trials, the last two years have seen an explosion of them across medicine. They have come from academic health care organizations, research funders, policy makers and third-party analysts such as the Milken Institute’s FasterCures initiative. They are not just critiques, however. They are calls to action, and in many cases, they offer roadmaps to improvement.
A HISTORICAL, AND CURRENT, PROBLEM
The reasons for the lack of ethnic and racial diversity in United States’ clinical trials are in some ways completely obvious to people who have a basic grasp of this country’s history – and in others, so complex and nuanced that they have been difficult to fully explain.
But there are two core historical points that recent analyses make plain:
- The American medical system has mistreated people of color for centuries.
- As a result, many people of color have mistrusted the American medical system for centuries.
These two points come together most infamously in what was called the “Tuskegee Study of Untreated Syphilis in the Negro Males.” This clinical trial was approved and led by the United States Public Health Service, which sent researchers to work at the Tuskegee Institute in Alabama (now Tuskegee University). Researchers “enticed” hundreds of black men with syphilis to enroll in the study with incentives that would not normally be available to them, including regular health care, according to an account of the study from Tuskegee’s National Center for Bioethics in Research and Health Care. They were told they would be treated for “bad blood”.
The study began in 1932. Even though penicillin had become the standard treatment for syphilis by 1947, that treatment was withheld from the study participants. Dozens of the men died from their infections. Many of their family members also contracted syphilis, including babies born with congenital syphilis infections. The study only ended in 1972, when it was exposed in news articles, after so many were infected and suffered needlessly.
In short, a group of people already experiencing marginalization and racism were convinced to participate in medical research with lies, and the harm they experienced was one of the goals of the research. Given this and other medical-historical traumas “it would be illogical and irrational not to approach providers and health care entities with some level of skepticism,” wrote researchers from Vanderbilt University in a widely-cited publication on equity and trust in medical research.
“That’s all completely true,” says Dr. Walker. It also doesn’t tell the whole story.
“People always bring up Tuskegee,” she says. “But there were people mistreated when they went to the hospital today. People don’t want to confront that quite as much, because we believe we’re good people now. What we need to do is divorce the often false individual moral and character accusations from the actions we need to make for structural and behavioral changes. This also requires us to look for our blind spots when it comes to these issues.”
There are many measures of how skewed racial and ethnic representations still are in clinical trials; an FDA summary of drug trials from 2015 through 2019 showed that 76$ of participants were White, for example, while approximately 58% of the overall U.S. population identifies as White.
Valencia Walker, MD, neonatologist and associate chief of diversity and health equity officer at Nationwide Children’s Hospital
People always bring up Tuskegee, but there were people mistreated when they went to the hospital today. People don’t want to confront that quite as much because we believe we’re good people now. What we need to do is divorce the often false individual moral and character accusations from the actions we need to make for structural and behavioral changes. This also requires us to look for our blind spots when it comes to these issues.”
Those statistics, though, are just the start, says Yasmeen Long, MA, director of the FasterCures center at the Milken Institute. She and her colleague Esther Krofah, MPP, executive director of FasterCures and the Center for Public Health, are authors of the report “Achieving Health Equity: An Action Plan to Address Diversity Across Clinical Trials and Biomedical Research,” released in November 2021.
“Participants in clinical trials, regardless of their age, rarely represent the actual patients and populations bearing the burdens of the disease under study,” she says.
That’s always been the case, but rarely has it been clearer, or received more attention, than during the COVID-19 pandemic.
THE RECENT ATTENTION
Through the first year of the COVID-19 pandemic in the United States, Black people, Hispanic/Latinx people and American Indian and Alaskan Native (AIAN) people had disproportionately high mortality rates compared to White people. The disparity in outcomes between minority populations and White people has decreased over time, but a February 2022 age-adjusted analysis from the Kaiser Family Foundation showed that Black, Hispanic and AIAN people were still about twice as likely to die from COVID-19 as White people.
The disparities were alarming and resulted in calls, including from Anthony Fauci, MD, director of the National Institute for Allergy and Infection Diseases, for the pharmaceutical industry to overrepresent people of color in COVID-19 vaccine trials.
Pfizer and Moderna communicated about their efforts to recruit more people of color; Moderna actually slowed its trial in adults to do a better jobs of minority recruitment. While never coming close to Dr. Fauci’s goal, the trials did better represent minority populations than many previous ones.
Both the comparatively poor COVID-19 outcomes among minority populations, and the clear lesson that focusing on current interactions and structures within the medical trials systems could improve representation, combined to draw greater attention to the issue.
“The COVID-19 pandemic brought health inequity into starker focus, and it’s clearer than ever that when trials are appropriately diverse, they can improve the health of the broader populations, including urban and rural populations and populations who have limited use of technology,” says Long.
The problems reach beyond history into 2022. The sometimes-under-resourced hospitals where people of color are more likely to receive care have small numbers of clinical trials. It can be difficult to travel, or get time off work, to reach the relatively few academic medical centers that host clinical trials. Some research suggests that providers aren’t as likely to discuss clinical trials with people of color. Clinical trial recruitment efforts may not account for health literacy, the need for translated materials or other cultural issues.
Many of the recent calls-to-action hope to address all of these issues and more.
Katherine J. Deans, MD, chief clinical research officer at Nationwide Children’s Hospital
We have to better empower families to take part in research. We have to think about people, process and environment. We’re doing this work now because we want to continue to live our mission. We want to better live our mission. If we want to improve the health of all children, we have to make sure all children are represented in our research.”
THE WAY FORWARD
As nearly everyone will admit, it’s not going to be easy.
“We’re so guilty of wanting to come in with one sweeping change and say, ‘we fixed it,’” says Dr. Walker. “We didn’t get to this point in one year or three years or five years, but that’s how we’re trained to deal with things, because that’s how our grant system works. It’s how our political system works. If we are trying to change generations, centuries, of mistreatment, it doesn’t happen in a year.”
The FasterCures report proposes changes in community engagement, funding, data collection, workforce diversity and accountability across five huge stakeholder groups: federal and regulatory agencies, academic and research institutions, the biopharmaceutical industry, nonprofit and private research funders and clinical trials research sites.
Some of what FasterCures suggests is already happening, in fits and starts. For example, in February, a bipartisan group of members of Congress introduced the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act. Among other provisions, it includes a requirement of “Diversity Action Plans” from Investigational New Drug and Investigational Device Exemption applicants that lay out engagement and outreach strategies, and it would provide grant funding to community health centers to increase their capacity to participate in clinical trials and research.
Pediatric academic medical centers have a particular responsibility to ensure equity in trials, and places such as Nationwide Children’s already have many of the pieces in place to accelerate those efforts, says Katherine J. Deans ,MD, chief clinical research officer at Nationwide Children’s. the hospital’s new strategic plan is, in part, an effort to do just that.
“Integrating clinical research more deeply and broadly into clinical care is at the very heart of our new strategic plan. This is, in part, because we know that better integration will promote more inclusive access to research participation for families. By eliminating some of the barriers for underrepresented populations to participate in research, we are ensuring that the results of our research are more generalizable to these populations,” Dr. Deans says. “Bringing research to the point of care allows families to hear about opportunities from the doctors and nurses that they trust. It also means that starting with our schedulers and registration desks, we are thinking through how to connect families with research that matters to them.”
In addition, Dr. Deans sys, if nationwide Children’s and other hospitals are serious about better including underrepresented people, research studies need to be planned around their concerns, their needs and their time constraints.
“We have to better empower families to take part in research – not just participating in it, but also having a voice in what we study and how we study it,” Dr. Deans says. “We need to remember that we’re doing this work now because we want to continue to live our mission. If we want to improve the health of all children, we have to make sure all children are represented in our research.”
This article appears in the 2022 Spring/Summer print issue. Download the full issue.
Walker V, Pavlek L, Backes C. Expecting equity: reimagining the delivery of racial/ethnic representation in neonatal clinical trials. Journal of Perinatology. 2022 Jan; 42(1):1-2.
Long Y, Krofah E. Achieving Health Equity: an action plan to address diversity across clinical trials and biomedical research. Milken Institute FasterCures. https://milkeninstitute.org/report/clinical-trials-achieving-diversity. Nov 18, 2021.
Tuskegee University National Center for Bioethics in Research and Health Care. About the USPHS Syphilis Study. https://www.tuskegee.edu/about-us/centers-of-excellence/bioethics-center/about-theusphs-syphilis-study. Accessed March 17, 2022.
U.S. Food and Drug Administration. Drug trials snapshots summary report: 2015-2019. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots. Accessed March 17, 2022.
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