Abstract
African Americans, other minorities and underserved populations are consistently under- represented in clinical trials. Such underrepresentation results in a gap in the evidence base, and health disparities. The ABC Cardiovascular Implementation Study (CVIS) is a comprehensive prospective cohort registry that integrates social determinants of health. ABC CVIS uses real world clinical practice data to address critical gaps in care by facilitating robust participation of African Americans and other minorities in clinical trials. ABC CVIS will include diverse patients from collaborating ABC member private practices, as well as patients from academic health centers and Federally Qualified Health Centers (FQHCs). This paper describes the rationale and design of the ABC CVIS Registry. The registry will: (1) prospectively collect socio-demographic, clinical and biospecimen data from enrolled adults, adolescents and children with prioritized cardiovascular diseases; (2) Evaluate the safety and clinical outcomes of new therapeutic agents, including post marketing surveillance and pharmacovigilance; (3) Support National Institutes of Health (NIH) and industry sponsored research; (4) Support Quality Measures standards from the Center for Medicare and Medicaid Services (CMS) and Commercial Health Plans. The registry will utilize novel data and technology tools to facilitate mobile health technology application programming interface (API) to health system or practice electronic health records (EHR). Long term, CVIS will become the most comprehensive patient registry for underserved diverse patients with cardiovascular disease (CVD) and co morbid conditions, providing real world data to address health disparities. At least 10,000 patients will be enrolled from 50 sites across the United States.
Highlights
Introduction(2) Increasing difficulty of recruiting and retaining an appropriate human subject population for specific clinical trials
Initial priority conditions for the registry include diseases, such as heart failure and atrial fibrillation that have significant disparities in cardiovascular care. Both conditions have recently received approval of novel drug therapies, the clinical trials did not include a sufficient number of Black patients
This lack of evidence leaves practicing physicians struggling to determine if these drugs are more effective than existing treatments in this patient population
Summary
(2) Increasing difficulty of recruiting and retaining an appropriate human subject population for specific clinical trials These barriers disproportionately impact minorities and individuals with limited science and health literacy, in part due to a lack of cultural competence and language sensitivity among researchers. Barriers to clinical research may limit participation of minority patients and their physicians, as confirmed by our own focus group research [8], potentially widening disparities. CVIS will intentionally focus education and health literacy efforts on knowledge gaps in clinical research among patients and providers, including rationale and process to return research results to participants. CVIS will complement the All of Us Precision Medicine Initiative by addressing critical gaps in research translation that is relevant to NIH and NCATS strategic priorities
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