Fact checked byHeather Biele

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February 14, 2023
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Cognivue reports nearly 40% participation rate from marginalized groups in FOCUS study

Fact checked byHeather Biele
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The national Further the Objective and Clinical Understanding of Cognivue Study drew a 37% research participation rate from individuals in underserved and underrepresented populations, the neuroscience company reported in a press release.

The FOCUS study, which is designed to test Cognivue cognitive assessment screening products in the general population, included more than 28% participants who identify as Black/African-American, American Indian/Alaska Native, Asian, Native Hawaiian/other Pacific Islander or another non-white race. More than 12% of the study population identified as Hispanic.

United States with stethoscope
The FOCUS drew a 37% research participation rate from marginalized populations. Source: Adobe Stock

“I cannot overstate the value that this diverse data capture has brought to the FOCUS study,” Cognivue President and CEO Tom O’Neill said in the release. “Participants in research trials should represent the patients who will use the medical device, and this is often not the case, since people from racial and ethnic minority and other diverse groups are generally underrepresented in clinical research, especially research related to neuroscience.”

According to the release, typical scientific studies of this size average between 2% and 16% diverse participation.

“The great challenge in nearly all U.S. clinical trials is that their study cohorts are overwhelmingly European white, male and highly educated with post-college degrees,” James E. Galvin, MD, MPH, professor of neurology and psychiatry and behavioral sciences at University of Miami Miller School of Medicine and a Cognivue advisory board member, said in the release. “It is nearly impossible to understand how a test, a device or a medication will perform in the general population if we only consistently study one group and make little to no effort to include individuals from other racial, ethnic and educational backgrounds.”

He added, “Over one-third of FOCUS participants were from underrepresented minority groups. On top of this, more than half were women, and two-thirds reported an education of less than a college degree. FOCUS should be a blueprint for how research in the community should be and can be done.”