Abstract
Abstract Background One of the great challenges facing clinical trial recruitment is to have a representative sample reflective of the diversity of the US population. While racial and ethnic minorities compromise 39% of the United States population, they only account for 2%‐16% of clinical trial participants. 1 The aim of the FOCUS study was to collect cognitive testing data from a diverse population and develop normative ranges for Cognivue, the first FDA‐cleared computerized cognitive assessment device based on modern cognitive neuroscience. Cognivue Thrive provides a 5‐minute cognitive screen while Cognivue Clarity provides a 10‐minute comprehensive assessment, allowing both physicians and non‐physician clinicians to objectively and quantitatively access brain health beyond traditional paper and pencil cognitive tests. Method Cognivue partnered with Velocity Clinical Research to lead the recruitment efforts for the FOCUS study. The enrollment goal included an objective to enroll a group resembling the racial, ethnic, gender, and educational makeup recorded in the 2020 U.S. census data. Study subjects were recruited through local community outreach, participant referrals, and advertising. Recruitment was stopped once goals for specific sub‐groups were reached, to model real‐world outcomes. Cognivue Thrive and Clarity were administered to assess scoring and normative ranges and compared against performance on other neuropsychological test batteries within the diverse study cohort. Result The Cognivue/Velocity partnership resulted in recruitment of more than 1,500 subjects from 14 sites in 11 states with a mean age of 50.2±16.3y (range 18‐89), 59.2% female, and 51.8% with 12 years or less of education. Over 28% of subjects identified their race as Black or African American, American Indian or Alaska Native, Asian, Native Hawaiian or Pacific Islander, or other non‐white, and over 12% of participants identified as Hispanic or Latino. Conclusion Working in collaboration with Velocity, a clinical research partner with study sites throughout the United States, Cognivue was able to reach a 37% research participation rate of historically underserved and underrepresented populations in the national FOCUS study. 1 Clin Pharmacol Ther. 2015 Mar;97(3):263‐73. https://doi.org/10.1002/cpt.61 .