What have been the ethnic and racial demographics of patients enrolled in prospective chronic rhinosinusitis (CRS) studies relative to the corresponding geographic demographics of U.S. census data?
Explore This IssueAugust 2021
The racial and ethnic composition of patients enrolled in recent prospective U.S. CRS clinical trials does not reflect U.S. demographics, as minority demographic groups are significantly underrepresented in these studies.
BACKGROUND: Racial and ethnic disparities in clinical treatment and outcomes have been well established across medical disciplines, including otolaryngology. These disparities are interconnected with disparities in trial patient enrollment. Participant diversity in clinical trials is essential to obtain widely generalizable results. Therefore, trial enrollment disparities can affect overall healthcare outcomes.
STUDY DESIGN: Systematic review and population analysis.
SETTING: Department of Otolaryngology–Head and Neck Surgery, Columbia University Irving Medical Center, New York, N.Y.
SYNOPSIS: Researchers identified 83 CRS U.S. clinical trials published between 2010 and 2020 and compared pooled racial/ethnicity data to national corresponding regional census data. Of the 12,207 patients who participated in the studies, 81.67% were identified as White, 5.35% as Black, 1.27% as Asian, 0.02% as Pacific Islander, 0.12% as American Indian, and 11.57% as Other. Nationally, the racial composition of the study population was significantly different from 2018 U.S. census data, with underrepresentation of each minority group and overrepresentation of White patients. One exception was in the South and Midwest, where enrollment of Black patients was similar to U.S. census data. Authors cite contributing factors, including differences in disease incidence; care/trial access; socioeconomic factors; language barriers; patient beliefs/willingness; and investigator recruitment differences. Authors note how the interconnection of racial/ethnic disparities in clinical trial patient enrollment and in clinical treatments and outcomes produce greater potential for inaccurate data results. Study limitations included the potential for inaccurate race/ethnicity data and for overlapping patient populations among research consortia.
CITATION: Spielman DB, Liebowitz A, Kelebeyev S, et al. Race in rhinology clinical trial: A decade of disparity. Laryngoscope. 2021;131:1722-1728.