The ELEGANCE Registry: Working to Achieve Equity in Clinical Research Design

Abstract

Peripheral artery disease (PAD) disproportionately affects women and underrepresented, historically marginalized groups (UMGs); however, these patients are not well-represented in clinical research of PAD treatments. Most patients enrolled in trials are older white men. White women and underrepresented populations of any gender present differently and respond differently to therapies compared with white men. They must be represented in clinical studies of PAD in proportion to their numbers in the patient population to ensure generalizability of study findings and the development of optimal individualized care. The many obstacles to enrolling these populations in clinical studies include mistrust of the medical system, no proximity to clinics and providers who run clinical trials, limited understanding about the biomedical research process, language barriers, financial and transportation limitations, and inability to take time off from work or from caring for others in the household. Given the complexity of PAD and the need for clinical data from diverse patient populations that are not available from existing clinical trials, the authors created an international registry of patients treated with advanced therapies for PAD. The Drug-ELuting REGistry: ReAl-World Treatment of LesioNs in the Peripheral VasCulaturE (ELEGANCE) registry is a prospective international postmarket registry examining real-world use of drug-coated devices in patients with symptomatic PAD and includes several novel design elements aimed at enrolling at least 40% women and 40% underrepresented patients. As of December 1, 2022, over 800 patients were enrolled in the registry, ahead of target enrollment rates; of these, 44% are women and 47% are UMGs.