How Boston Scientific is working to improve clinical trial diversity – and why it matters

Over the past century, advances in cardiovascular care have translated to longer, healthier lives for many people – but not in equal measure. In fact, as research has illuminated, the very patients who could benefit most from lifesaving diagnostic tools and treatments often aren’t getting them.

Case in point: Black people in America are 30% more likely to die from heart disease than non-Hispanic white people. Recent studies have found that social determinants of health, including education and poverty, are more likely to blame than biological differences. Black patients are also far less likely to be treated with medical interventions for atrial fibrillation – a heart rhythm disorder that raises the risk of stroke or heart failure – or for peripheral artery disease (PAD), which can lead to amputation.

Women of any race or ethnicity are at risk, too: They’re twice as likely as their male counterparts to die following a heart attack, in part because they may display different symptoms than men do before an attack occurs.

As a leading manufacturer of medical devices, Boston Scientific has long been committed to overcoming disparities in care. More than 20 years ago, we founded Close the Gap to spearhead these efforts.

“The driving motive is to champion health equity for women and people of color,” says Camille Chang Gilmore, vice president of Human Resources and global chief Diversity, Equity and Inclusion officer. “It’s about improving the diverse patient experience and making sure all who would benefit from lifesaving therapies know about them.”

It’s also important to ensure that those lifesaving therapies are effective for diverse groups of patients.

Why clinical trial diversity is so critical

Currently, Black people comprise nearly 14% of the U.S. population, but less than 7% of all clinical trial participants. Hispanic people make up about 19% of the population, but less than 6% of clinical trial participants are Hispanic. Women are also underrepresented in clinical trials.  

Lack of adequate representation is a problem for several reasons.

“The big one from an industry perspective is generalizability,” says Iñaki A. Martin Cossio, clinical manager, Health Equity, Close the Gap. “It’s important that we have data on how our products perform with all of the diverse patient groups that need them so we can accurately understand outcomes for everyone.”

And if a product doesn’t work for certain people, it’s crucial to know that too so they can get a treatment that will.

“We need to learn which patients will do better with which device based on their race, where they live, their comorbidities and so on,” says Michael Jaff, DO, chief medical officer for Boston Scientific’s Peripheral Interventions business.

In the past, clinical trial investigators have often claimed that recruiting a diverse group of participants was too challenging. But through the PLATINUM Diversity Trial, a first-of-its-kind study launched in 2014, Boston Scientific enrolled more than 1,500 women, Black people, Latinos and Native Americans to examine how stent technology works on underserved populations compared to white men. The company took away many learnings about how to recruit a broader population to its clinical trials.

For one thing, some underrepresented groups remain understandably wary of scientific research, based on a history of systemic mistreatment, says Martin Cossio. It doesn’t help that clinical trial investigators don’t often reflect the diversity of the patients they’re hoping to study.

“When you have a physician or scientist running the clinical trial from the same demographic group as the population you’re trying to reach, it helps build trust,” says Martin Cossio.

It’s a lesson Dr. Jaff and other investigators took to heart in planning the ELEGANCE patient registry. Launched in 2021, ELEGANCE is a large, global post-market registry of people who received one of two Boston Scientific treatments for PAD. Clinical trials evaluating treatments for PAD often lack representative patient populations, a new systematic study reveals. The ELEGANCE registry, however, has an enrollment goal to include at least 40% women and 40% underrepresented people of color, a benchmark it has surpassed.

To achieve these ambitious numbers, study sites were strategically selected based on the latest census data at the zip code level, historical trial participation data as well as Medicare claims and other data. The study team closely monitors their 40% diversity enrollment goal of non-Hispanic white males and takes proactive action by partnering with site investigators struggling to meet it.

Notably, 50% of the ELEGANCE steering committee and site principal investigators come from underrepresented groups themselves. Early findings from ELEGANCE suggest that women and people of color tend to have more severe PAD by the time they receive treatment with a drug-eluting device. They’re also more likely to have diabetes. Insights like these may help physicians to better tailor their care based on their patients’ demographics.

New ideas for lowering the barriers to clinical trial participation

Today, Close the Gap collaborates with Boston Scientific’s clinical research leaders to help identify and address opportunities to improve enrollment for underrepresented patient populations, supporting eight clinical trials in 2023 alone. Close the Gap also helped study teams develop three diversity plans to meet U.S. Food and Drug Administration (FDA) guidelines for clinical trial diversity.

But there is always more work to be done.

This year, Boston Scientific announced the formation of the Clinical Health Equity Collaborative Tiger Team (CHEC-TT) – a company-wide initiative to increase representation of women and people of color by transforming the way we design and implement clinical trials.

In some cases, moving the needle might simply come down to better and more intentional communication. Says Martin Cossio: “We did a market research study a couple of years ago, and a lot of patients said that they would be willing to participate in a clinical trial – but no one had ever asked them.”

 

Learn more about how Close the Gap is working to eliminate disparities in health care so we can reach more women and people of color – and save more lives.