“There have been studies that demonstrate women have a better chance at recruiting patients. And also for patients from underrepresented
minorities, if they see another minority as a PI, there is a higher chance of them joining studies.” —YOLANDA BRYCE, MD
“This is the only PAD clinical trial of its size that is female-led,” Dr. Kohi said. “Having industry support our study and prioritize a diverse steering committee shows that they’re very serious and passionate about diversity and inclusion and know how impactful this is for physicians and patients.”
That passion is shared by all involved in the trial, Dr. Kohi says. It’s driven the commitment on the physician side to recruit as many URM and women as possible, because everyone involved understands the impact of the data.
Recreating the model While ELEGANCE may be unique in its enrollment pledge, Drs. Kohi and Bryce are hopeful that many trials going forward will include similar goals.
Dr. Bryce has already begun implementing demographic end goals on her own research. She is currently working on a PAD screening trial which begins soon and will aim to sample Black patients so they represent 25% of the study population. Though her trial and the ELEGANCE registry are the first studies she’s been involved in with these kind of enrollment goals, she believes they’re unlikely to be the last.
“The NIH has begun mandating that for grant funding, you have to provide percentages of the different demographics you’re hoping to enroll,” Dr. Bryce said. “The world is moving that way anyway, because it doesn’t make sense to fund a large trial if the results aren’t generalizable. And in order to move forward as physicians and scientists, we have to make sure that our studies will evoke results that
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help a big portion of our patients. Not just a fraction.”
It’s a simple model that should be easily replicated, Dr. Kohi says, but physicians may have to be more dedicated to ensuring studies become more diverse from the top-down.
“We may have to become more draconian,” she said. “When we, as PIs, are approached by industry and asked to be involved in trials, we should ask to see the makeup of the steering committee and the suggested PIs and sites. And if the leadership, the PIs and the sites are not diverse, we should not participate in the study.”
ELEGANCE outcomes In advocating for more diverse trials, physician researchers may be able to point to the success of the ELEGANCE registry, which has successfully completed its enrollment goal: As of July 2022, 46 sites and 579 patients were enrolled, of which 41.6% are women and 40.6% are underrepresented minorities.10
“When we first started, people would ask ‘Well, what if you fail?’” Dr. Kohi said. “Failure was never an option. There was never a doubt in my mind that we wouldn’t succeed and so far we have surpassed our goal. Now all we need to do is to continue and show the rest of the scientific community that such a trial design is possible and should be the new norm.”
Glossary
Bias: A form of prejudice that results from our perceived need to quickly classify individuals into categories.
References
1. Aday AW, Matsushita K. Epidemiology of peripheral artery disease and polyvascular disease. Circ Res. 2021; 128:1818–1832. doi: 10.1161/ CIRCRESAHA.121.318535.
2. Lin J, Chen Y, Jiang N, Li Z and Xu S. Burden of peripheral artery disease and its attributable risk factors in 204 countries and territories from 1990 to 2019. Front. Cardiovasc. Med. 2022;9:868370. doi: 10.3389/fcvm.2022.868370.
3. Altin SE, Gitto M, Secemsky EA, Rao SV, Hess CN. Sex-based differences in periprocedural complications following lower extremity peripheral vascular intervention. Circ Cardiovasc Interv. 2022;15(8):e011768. doi: 10.1161/ CIRCINTERVENTIONS.121.011768.
4. Hackler EL, Hamburg NM, White Solaru KT. Racial and ethnic disparities in peripheral artery disease. Circ Res. 2021 Jun 11;128(12):1913-1926. doi: 10.1161/CIRCRESAHA.121.318243.
5. Shu J, Santulli G. Update on peripheral artery disease: Epidemiology and evidence-based facts. Atherosclerosis. 2018 Aug;275:379-381. doi: 10.1016/
j.atherosclerosis.2018.05.033.
6. Virani SS, et al. Heart disease and stroke statistics—2020 update: a report from the American Heart Association. Circulation. 2020;141:e139–e596. doi: 10.1161/ CIR.0000000000000757.
7. Clark LT, Watkins L, Piña IL, Elmer M, Akinboboye O, Gorham M, Jamerson B, McCullough C, Pierre C, Polis AB, Puckrein G, Regnante JM. Increasing diversity in clinical trials: Overcoming critical barriers. Curr Probl Cardiol. 2019 May;44(5):148- 172. doi: 10.1016/j.cpcardiol.2018.11.002.
8. Hirsch AT, Allison MA, Gomes AS, Corriere MA, Duval S, Ershow AG, Hiatt WR, Karas RH, Lovell MB, McDermott MM, Mendes DM, Nussmeier NA, Treat-Jacobson D; on behalf of the American Heart Association Council on Peripheral Vascular Disease, Council on Cardiovascular and Stroke Nursing, Council on Cardiovascular Radiology and Intervention, Council on Cardiovascular Surgery and Anesthesia, Council on Clinical Cardiology, and Council on Epidemiology and Prevention. A call to action: women and peripheral artery disease: a scientific statement from the American Heart Association. Circulation. 2012. doi/10.1161/ CIR.0b013e31824c39ba.
9. National Institute on Minority Health and Health Disparities. Resource: Diversity and inclusion in clinical trials. 2022.
nimhd.nih.gov/resources/ understanding-health-disparities/diversity-and-
inclusion-in-clinical-trials.html.
10. Boston Scientific. ELEGANCE patient registry focuses on women and people of color to address inequities in the treatment of peripheral arterial disease. May 2021.
news.bostonscientific. com/ELEGANCE-Patient-Registry#_edn1.
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