Clinical Research Deliberately Recruits Previously Underrepresented Study Subjects
May 17, 2021
In April, the first study subject—a woman in her mid-80s—was enrolled in ELEGANCE, an international patient registry and post-market clinical study that is breaking new ground in clinical research: It has an aggressive goal to enroll no less than 40% women and 40% underrepresented minorities, specifically members of the Black and Hispanic communities. The study aims to expand the body of clinical evidence on the outcomes of patients diagnosed with peripheral artery disease, particularly women and people of color.
“By including more diverse patient populations in clinical research like the ELEGANCE patient registry, we can see how treatment of the disease plays out in the real world and ensure that all patients have equitable access to good outcomes,” said Dr. Maureen Kohi, global principal investigator of the ELEGANCE registry.
Approximately 200 million people around the world are affected by peripheral artery disease[i], a common circulatory problem that disproportionately affects Black men and women: In men and women over the age of 60, an estimated 27% of the Black population are expected to have peripheral arterial disease compared to 11% of the white population and 11% of the Hispanic population.[ii] In a recent survey, 65% of Black patients expressed they would be willing to participate in a clinical study, yet 69% reported they have never been asked to participate.[iii]
Clinical studies for peripheral artery disease have typically not reflected the true patient population of the disease, representing a microcosm of a larger challenge in clinical studies: Women represent nearly 51% of the U.S. population, but in medical device studies they make up only 33% of enrollees.[iv],[v] Hispanic individuals account for more than 18% of the U.S. population[vi], yet only 1 - 6% participate in medical device studies.iv,v Black community members represent 13.4% of the U.S. population, but make up only 5 – 7% of overall clinical study participants.iv,v
“As healthcare professionals, it is our responsibility to ask ourselves why people who are the most affected by the disease are not being included in research about treating the disease,” said Dr. Kohi, who is committed to ensuring that women and underrepresented minorities suffering from peripheral arterial disease don’t also suffer from health care disparities. “Underrepresented patient populations such as women and minorities stem from a lack of diversity in the principal investigators of clinical trials,” she said. Such underrepresentation is not a factor in the ELEGANCE registry: More than 50% of the steering committee is composed of physicians who identify as female and underrepresented minorities.
The ELEGANCE patient registry, which is sponsored by Boston Scientific, is a post-market study that is gathering real-world clinical evidence to assess the long-term outcomes of patients after being treated with the Ranger™ Drug-Coated Balloon and the Eluvia™ Drug-Eluting Stent. Up to 5,000 patients will be enrolled in the global registry and patients will be followed for five years.
Dr. Maureen Kohi, M.D., FSIR, FCIRSE, FAHA is professor and chair of the Department of Radiology at the University of North Carolina at Chapel Hill. She is executive council member of the Society for Interventional Radiology, development division chair of the Society of Interventional Radiology Foundation, scientific chair of the Society of Interventional Radiology’s Annual Meeting, associate editor for the Journal of Vascular and Interventional Radiology, past chair of the Women in Interventional Radiology Governing Council, and member of the Vascular Interventional Advances Physician Board. She also serves as the president of the Western Angiographic and Interventional Society.
[i] Shu J, Santulli G. Update on peripheral artery disease: Epidemiology and evidence-based facts. Atherosclerosis.
[ii] Virani SS, et al (2020). Heart disease and stroke statistics—2020 update: a report from the American Heart Association. Circulation;141:e139–e596. doi: 10.1161/CIR.0000000000000757.
[iii] This resource is compiled from quantitative and qualitative survey results, initiated by Boston Scientific,
from patients who identified as being Black, Caucasian or Hispanic.
[iv] Clark, L. et al. (2019). Increasing Diversity in Clinical Trials: Overcoming Critical Barriers. Current
Problems in Cardiology. 44(5). Pg 148-172
[v] Zhang et al. (2013). Reporting and Representation of Ethnic Minorities in Cardiovascular Trials: A Systemic Review. American Heart Journal. 166 (1). Pg 52-57
[vi] United States Census Bureau. 2019 Population estimates – Quick Facts United States