Why Clinical Trial Diversity Is So Important - and What the Healthcare Sector Can Do

Physicians prescribe medication and design treatment and therapy plans for their patients based on the most recent clinical trial research available, much of which is utilized by the U.S. Food and Drug Administration to evaluate safety and efficacy. But how can a provider create equitable, evidence-driven patient plans when large subsets of the population — namely women and people of color — are not equitably represented in clinical research trials?

Across the healthcare landscape in the United States, the quality of care for diverse populations is severely hindered when those same diverse populations are excluded from clinical trials. This absence of representation can create major gaps in treatment. Clinical trials that disproportionately test their products on white males, for example, run the risk of creating a product that may not serve the rest of the patient population as effectively.

Medical technology company Boston Scientific is among the organizations working to reverse the under-representation of women and people of color, specifically Black patients, in clinical trials. Its aptly named Close the Gap program aims to level the medical playing field. The holistic program touches many pain points to address health inequities, but Boston Scientific Medical Director Dr. Paul Underwood said proper representation in clinical trials is not to be overlooked.

“By promoting clinical research in diverse communities, you’re promoting a higher quality of care in those communities as well,” Dr. Underwood told TriplePundit. “Clinical research allows us to look at practice patterns and understand who’s being treated and who’s not being treated.”

The Phoenix-based clinical physician-turned-medical director said understanding the demographics and epidemiology of patients in a particular ZIP code, for example, can prove to be an extremely useful tool to monitor if the patients enrolling in clinical trials are representative of the populations in that location.

The approach Boston Scientific has taken through Close the Gap has evolved as the team builds on nearly 20 years of progress. Close the Gap’s team of medical professionals and health equity experts now work directly with clinical teams with the aim of creating a roadmap for achieving diversity in clinical trials, Dr. Underwood said. They’ve built dashboards and datasets with fields for demographic information. As patients are enrolled into trials, Boston Scientific researchers can see this data in real time to understand how sites are progressing with enrolling diverse populations.

The company is not starting from scratch. Back in 2017, the Boston Scientific-sponsored Platinum Diversity Trial sought to better understand how social, clinical, behavioral, and economic determinants affect quality of care and health outcomes for patients with coronary artery disease. Whereas clinical trials in cardiology have a track record of featuring disproportionately low numbers of women and people of color, the first-of-its-kind Platinum Diversity exclusively studied women and people of color. The study monitored 1,501 patients across 52 sites representing understudied populations, with initial findings released in 2017. "The most vulnerable populations who are at the greatest risk of heart disease are the ones who are being studied in clinical trials the least,” Dr. Underwood, who was part of the study team, said at the time — and despite recent progress, the overall sentiment remains true today.

More recently, the company launched the ELEGANCE study, an international patient registry and post-market clinical study aiming to enroll no less than 40 percent women and 40 percent underrepresented minorities — specifically Black and Hispanic patients — diagnosed with peripheral artery disease.

Barriers to equity in clinical trials

Medical companies working toward FDA approval of therapies may point to longer trials due to lengthy recruitment periods to assure diversity in the research. But the Platinum Diversity trial myth-busts the notion that recruiting diverse patients prolongs the research process, Dr. Underwood said. On the contrary, he mentioned the thoughtful investigators participating in the trial led to faster recruitment of patients.

Plainly, diverse populations are often omitted from clinical trials because they are not asked to participate. Whether it’s explicit or implicit bias, women and people of color are too often kept on the sidelines. For example, studies show that when both white and Black patients are asked to participate in a trial, each group’s acceptance rate stands at roughly 50 percent. The difference, of course, is that Black patients are less likely to be asked to join in the first place, Dr. Carmen Guerra, vice chair of diversity and inclusion in the University of Pennsylvania’s department of medicine, recently told Clinical Trials Arena.

In the medical field, bias can also be a two-way street — in other words, participation from Black people and other people of color may be lower because of distrust in the medical system stemming from historic and modern-day racism and inequities seen in the industry. Close the Gap seeks to ameliorate that distrust through everyday awareness raising. Further, the program’s team of medical professionals and health equity experts seek to diversify not only their patient populations, but also the physicians they partner with, the investigators they recruit, and ancillary services like steering committees and core labs. Diversity at every step can help promote a comfortable space for people of color to participate in trials.

A changing tide: “More eyes looking”

Despite wreaking worldwide devastation, the COVID-19 pandemic was most sharply felt in the United States by communities of color. Data from the U.S. Centers for Disease Control and Prevention (CDC) highlight that Black or African American, Latino, American Indian and Alaska Native people experienced higher rates of COVID-19-related hospitalization and death compared with white populations. This revelation is yet another reminder that health inequities remain prominent today — and thankfully it is attracting more attention.

For his part, Dr. Underwood said he’s seen a “tremendous amount of progress” made in closing the health disparity gap — and he hopes the disparities revealed through the pandemic can help spur more urgent change.

“Now that we have more eyes looking at it and more heads thinking about it, we have a much greater chance of having a meaningful impact than perhaps in the past,” he said.

If companies remain unconvinced of the medical benefits clinical trial diversity can reap for all populations, the financial incentives should grab their attention. Beyond providing more equitable care and treatment options it’s just good business, Dr. Underwood said. “Everybody sees that having diversity is an advantage,” he told us. “Companies that are successful at figuring this out will have a greater impact on the marketplace than those that don’t.”

After all, the FDA through the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) has signaled its prioritization of clinical trial diversity (though the law recommends diversity as opposed to requiring it). If a company can devise a strategy to promote and enhance diverse enrollment, the FDA may be less likely to delay product approval due to inadequate data representation.

Though Dr. Underwood said he misses caring for patients one-on-one, he calls his transition from practicing cardiologist to medical director “fantastic.” He feels that he, and his company, have a responsibility for people “anywhere in the world,” not just those in his waiting room. “We must challenge ourselves to always be mindful of what can we do as a company to improve diversity, so we can reach all of the people who may have the illness,” he said.

This article series is sponsored by Boston Scientific and produced by the TriplePundit editorial team.

Image courtesy of Boston Scientific