How Boston Scientific is working to improve clinical trial representation – 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 shown, the very patients who could benefit most from lifesaving diagnostic tools and treatments often aren't getting them.

Studies have found that systemic barriers within the healthcare system can limit access to specialty care and cause treatment gaps that are more likely to drive disparities in care than biological differences. For example, in the United States (U.S.), women are twice as likely as men to die following a heart attack. Black patients are far less likely than non-Hispanic white patients 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.

As a leading manufacturer of medical devices, Boston Scientific is committed to overcoming disparities in care. This work aligns with our values, but it's also good science. Specifically, improving patient representation in clinical trials can strengthen the evidence behind new treatments, build confidence among patients and healthcare providers and help ensure that innovations reach all patients that need them.

For more than 20 years, Close the Gap (CTG), Boston Scientific's health equity initiative, has worked to improve clinical trial representation as part of its mission to increase access to care.

"CTG helps remove barriers that can prevent historically underserved populations from accessing therapies that could make a major difference in their lives," says Kenneth Stein, M.D., Boston Scientific senior vice president and global chief medical officer.

Why clinical trial representation is so critical

In the U.S., Hispanic people make up about 19% of the population, but less than 6% of cardiovascular clinical trial participants are Hispanic. Black people comprise nearly 14% of the U.S. population, but less than 7% of all cardiovascular clinical trial participants. Women are also underrepresented in randomized control trials for a range of medical fields and make up only 35% of cardiovascular clinical trial participants.

Lack of adequate representation is a problem for several reasons.

"The big one from an industry perspective is generalizability," says Iñaki A. Martin Cossio, senior manager, Health Equity, CTG. "It's important that we have data on how our products perform in a broad range of patients who may benefit from the therapy so we can accurately understand outcomes across patient populations."

Having data from a diverse patient population can also increase treatment adoption. When healthcare providers can show patients evidence that a medical device works for their specific demographic, they are more likely to perceive the device as a viable option.

Advancing representation, one trial at a time

In the past, clinical trial investigators have often claimed that recruiting a representative group of participants was too challenging. One contributing factor is that some historically underrepresented groups remain understandably wary of scientific research, based on a history of systemic mistreatment and insufficient knowledge about clinical trials.

In the face of those challenges, CTG has supported 24 Boston Scientific clinical trials to date, from site selection to enrolling and retaining patients. For example, CTG created the Demographic Analysis Report (DAR), a data-driven tool that uses zip code-level data about demographics, disease diagnosis, treatment rates and historical enrollment data to identify sites with potential to enroll historically underrepresented patients.

Additionally, before patients enroll in a clinical trial, they must understand and sign an informed consent form (ICF). But the language in these forms can be difficult to understand. CTG has developed a patient-centric ICF with simplified language, a summary of key information, a table of contents and visual elements. Developed with input from health literacy experts and patients, the new format aims to help more patients understand clinical trial participation, increase trust in study teams and lead to more informed decisions about trial participation.

As a result of our efforts, we have made steady progress to gradually increase representation:

• Most recently, our ADVENT Post Approval Study (PAS) study, designed to study the FARAPULSE Pulsed Field Ablation Platform, completed enrollment with 63% women and 43% historically underrepresented populations. These enrollment rates exceed those reported in comparable industry studies.¹
• Our SIMPLAAFY study for left atrial appendage closure (LAAC) enrolled nearly 43% women,² which is significantly higher than the 36% average female enrollment in LAAC studies in our industry.
• ELEGANCE, a global post-market PAD registry launched in 2021, continues to surpass its goal of enrolling at least 40% women and 40% underrepresented people of color, providing real-world evidence that these groups often present with more advanced PAD and higher rates of diabetes at treatment. Notably, 50% of the ELEGANCE steering committee and site principal investigators come from underrepresented groups themselves. "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.
• Our PLATINUM Diversity Trial was a first-of-its-kind study that enrolled more than 1,500 women, Black people, Latinos and Indigenous People with carotid artery disease to examine how stent technology works on underserved populations compared to white men.

Our research should reflect all of the patients we serve. "Ensuring clinical trials reflect the diversity of real-world patients is a critical challenge. We must help ensure that our therapies are effective and accessible for all the patients who need them," says Dr. Stein.

Learn more about how we're working to help ensure meaningful innovation reaches the patients that need it in this video from Sam Conaway, SVP, president of Cardiology and chair of Close the Gap.