Who Are We Missing? Reporting of Ethnicity, Race, and Sex‐Specific Populations in Clinical Trials

ow enrollment in randomized clinical trials (RCTs) hinders cardiovascular medicine advances. 1,2This disproportionately affects Black, Hispanic and Latino, and female patients who have disproportionately higher rates of cardiovascular risk factors and worse outcomes. 1Prior studies evaluated individual diseases, limited populations, and older trials, and used prior National Institutes of Health race and ethnicity definitions. 1,2Therefore, our objective was to quantitatively evaluate Black, Hispanic and Latino, and female patients' representativeness using US disease and risk factor prevalences across contemporary cardiovascular trials.We hypothesized that these populations would be underrepresented across trial categories.We performed a systematic PubMed/Medline review of cardiovascular disease or risk factor RCTs published from 2017 to 2022 that enrolled >100 individual US adults following Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) US guidelines.Two reviewers (E.B.F., I.K.) screened and selected studies meeting eligibility criteria.A third reviewer (A.L.) adjudicated disagreements.The University of Pennsylvania Institutional Review Board exempted this study (PROSPERO: CRD42023384196).We abstracted inclusion criteria, total patients, publication year, funding source, trial intent (treatment, prevention, diagnosis, safety), intervention type (medication, device, procedural, behavioral), and enrolled populations by race, ethnicity, and sex.We classified trials as enrolling patients with heart failure, coronary artery disease, type 2 diabetes, atrial fibrillation, valvular disease, stroke, hyperlipidemia, and peripheral arterial disease.To describe representativeness of Black, Hispanic and Latino, and female patients in RCTs relative to their US prevalence, we estimated participation-to-prevalence ratios (PPRs) averaged for each cardiovascular disease or risk factor using the American Heart Association Heart Disease and Stroke Statistics 2023 Update for prevalence data. 3 PPRs are calculated by dividing the proportion of the population of interest enrolled in each type of RCT by the corresponding proportion of US disease or risk factor prevalence. PPRs <0.8 indicate underrepresentativeness and >1.2 indicate overrepresentativeness. 2 We calculated unreported race, ethnicity, and sex prevalence using reported intersectional prevalences (e.g., Black, not Hispanic or Latino, and female) and validated 2022 American Community Survey Census data.