AHA-Backed Study Reveals Ongoing Lack of Minority & Female Participation in Cardiometabolic Clinical Trials

May 30, 2020 | American Heart Association, Cardiovascular Disease, Heart Failure, Metabolic Disease, Patient Enrollment, Patient Recruitment, Social Determinants of Health

AHA-Backed Study Reveals Ongoing Lack of Minority & Female Participation in Cardiometabolic Clinical Trials

Unfortunately, yet another report reveals the dearth of women and minorities, especially African Americans’ representation in clinical trials in the critically important cardiovascular and metabolic therapeutic domain. The results of a recent study published in the Journal of the American Heart Association—part of the American Heart Association—reveals that various demographic groups continue to be “underrepresented” in the study of novel cardiometabolic medications with no real evidence of improvement with enrollment numbers over the past decade. This possibly is part of a worsening trend where a bifurcated world exists—with overall declining life expectancy, at least in America, is driven by issues associated with the social determinants of health. A tale of two worlds emerge.

Dangerous Situation

Cardiovascular and cardiometabolic diseases (combining both cardiovascular and metabolic) represent the leading cause of death around the world. With Type 2 diabetes involved, such risks increase the risk of cardiovascular disease four-fold in women. 

Minority groups such as Blacks, Hispanics, and Native Americans face higher probabilities of facing these diseases. As researchers such as Brandon Muncan (State University of New York) have commented, while cardiovascular disease by itself leads to the death of people in the United States, it “poses a unique and multilateral burden to racial/ethnic minorities.” That racial and ethnic minorities face graver concerns on the cardiovascular front is well established. This is also the known case of minorities in regards to metabolic syndrome and obesity.

Keeping away from research

This TrialSite News author was involved with the largest patient recruitment organization at the time in the United States—if not the world—two decades ago. Back then, it was already apparent that pharma sponsors struggled to fill certain clinical trials with the appropriate level of minority and, in some cases, female patients in regards to cardiovascular and diabetes type 2 trials. Frankly, for over two decades there have been calls from government, academia, non-profit advocates, and industry to somehow get minorities and other “underrepresented” populations more active in clinical research. Even back then, the idea was that by employing clinical research as a care option, high-risk groups could be cared for under the research umbrella.

Undoubtedly, there have been many good-faith attempts over the years to initiate programs to engage and active minority groups to incentive more research participation. As the American Heart Association (AHA) notes in its press release, the lack of gender and racial diversity in research—in this case in the context of cardiometabolic diseases—has been a point of concern for researchers for a long time. By 1993, the U.S. Food and Drug Administration even established guidelines to increase the diversity of participants in clinical trials. Any number of federal programs have pumped considerable capital into such initiatives.

The Latest Evidence

In this latest study, researchers studied 10-year participation trends of women and racial and ethnic minorities in pivotal trials supporting the approval of new cardiometabolic medicines. By examining racial and ethnic enrollment data from nearly 300,000 trial participants, they found that on average:

· Women accounted for only 36% of trial participants

· 4% of trial participants were Black

· 12% of trial participants were Asian

· 11% of trial participants were Hispanic/Latino

Summary of Analysis

With the rise of biologic, targeted precision therapies comes the need for more diversity in clinical research. After all, the market for these drugs is everyone—isn’t it? Corresponding study author Muhammad Shahzeb Khan, MD, with John H. Stroger, Jr. Hospital of Cook County (Chicago) noted, “Demographic characteristics such as race and gender may have contrasting effects on medication response, which may inadvertently lead to variation in treatment outcomes and survival.” Dr. Khan continued, “It is important that individuals who participate in these trials are representative of the patients who will be treated with these medicines in clinical practice.”

Khan et al. find the same trends as was the case decades ago—that women and racial minorities don’t participate in clinical research nearly as much as White males; this ongoing and unfolding dynamic leads to A) implications involving research and how new therapy study may lack generalizability across populations and B) health equity as certain groups or demographics continue to access novel potentially life-saving advanced therapies while other groups may grow sicker due to cardiovascular and metabolic disease and eventually die sooner.

Study after Study

TrialSite News covers these types of studies as they are important to remind the society as to the ongoing inequality faced by many and how perhaps economic and social factors impact health. The social determinants of health are real and concerning as sizable public expenditure is allocated to the care of large segments of the population. Yet the overall health conditions for many groups worsen while expenditure rises. This cannot be sustained. The provider and research community understands the problem but isn’t sure as to how to resolve and transcend the current lack of participation. Hence study after study reveals comparable results, yet nothing drastically changes. 

A Tale of Two Worlds

A long time ago, in a nation far away from the North American continent, Mr. Charles Dickens summarized a growing societal chasm that would rip apart what was one of the greatest, wealthiest societies of that time:

“It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity; it was the season of light, it was the season of darkness, it was the spring of hope, it was the winter of despair.”

Fast forward to today and from the lens of the overall healthcare condition of large segments of the American population, a bifurcated world emerges, greatly influenced by the “social determinants of health” (race and ethnicity, economic livelihood and access to care, diet and life quality, etc.).  

Hence what unfolds appears to be almost like different worlds coexisting—where the standards, norms, and more of what it is to be healthy materially diverge, and hence different demographic pockets emerge—from those living healthy lifestyle enclaves—often earning a high income, exercising daily—practicing yoga and training for marathons—to segments of society where obesity and type 2 diabetes become disturbingly standardized—seemingly taken for granted that “this is just the way life is.” In some urban centers, these drastically different existences can coexist literally within adjacent neighborhoods—especially in cities with extensive gentrification. 

In this world, frankly, the opportunity for those with the education, drive, and creative entrepreneurial energy has never been better—heretofore unprecedented opportunity to develop new products and services for a corporate ecosystem hungry for disruption awaits those that can marshal the talent, capital, and resources. The race is less a factor really than the education and networks one has access to. But of course, residual institutionalized bias has a place in reinforcing societal patterns. 

Those fortunate enough to live in this world, in addition to all else good available, is access to what appears to be a forthcoming healthcare revolution, where new advanced therapies, technologies, and approaches, that a couple of decades ago would have been considered near science fiction, are common.

On the other hand, it is well understood among economists and sociologists that a transition to the globalized, service economy means for those that aren’t educated and importantly, plugged into thriving economic networks, must take on frequently low paying jobs that in many cases don’t offer health insurance. In this world, whereas many as 30 million Americans remain uninsured, the health care story becomes bleaker, and hence associated with an actual decline in life expectancy and quality of life. The dependence on a range of pharmaceutical products become essential to avoid cardiovascular and metabolic problems, for example, from degrading further in an attempt to reduce the probability of earlier mortality.

The world of Dickens, although a long time ago and far away, in some ways, reflects a recurring theme in human societies. As this manifests in the health of people, some demographics groups enjoy unparalleled health options, while large groups face an overall degradation of health and prosperity.

Moving Forward

When it comes to the lack of minority, female, or so-called underrepresented demographic groups’ participation in research, what is needed are more studies to reveal what is working out there. There are plenty of studies to show that these groups don’t participate enough. But it would be refreshing to understand what kinds of programs or initiatives might be producing some positive trends.

What kinds of programs and initiatives work? Even if only marginally to increase women, minority, and so-called “underrepresented” classes to participate in research. The National Cancer Institute (NCI) invests substantial sums into the Community Oncology Program (NCORP) for example. It would be beneficial to see a systematic study to assess the effectiveness of the allocation of these federal dollars into community-based clinical research as a care option initiatives.

Or for example, the American Heart Association’s signature “Go Red for Women®” initiative where the AHA advocates for increased representation in cardiovascular research studies for nearly two decades. It is an important endeavor by an influential association, empowering women to contribute to health research—including the development of a community of women scientists, researchers, and medical and health professionals to further raise awareness around women’s heart health by closing gender disparity gaps in research and clinical trials. This initiative has been expanded to COVID-19, where undoubtedly the same tends will persist. How have these AHA programs fared? What has been the result of education, engagement, and outreach ongoing?

Transcending the Existing Paradigm

TrialSite News sponsored a survey of African Americans in Southeast Texas. The findings were upbeat. African Americans want to dialogue about health, but fundamental health-trust barriers constrain progress. TrialSite News puts forth some interesting suggestions to overcome such barriers and hence transcend the current impediments to what could become a true health renaissance for all—perhaps for America and beyond.

Lead Research/Investigator

Muhammad Shahzeb Khan, MD, with John H. Stroger, Jr. Hospital of Cook County

Note, for other authors see the source.

Call to Action: Interested in shaking up clinical research to transcend the current status quo? contact TrialSite News for some proactive ideas. We won’t even charge you.

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