Race in Rhinology Clinical Trials: A Decade of Disparity

Area of Science:

• Otolaryngology
• Clinical Research
• Health Equity

Background:

• Chronic rhinosinusitis (CRS) affects a significant portion of the population.
• Clinical trial demographics are crucial for understanding disease prevalence and treatment efficacy across diverse groups.
• Previous research has not comprehensively assessed the representativeness of patient populations in CRS studies.

Purpose of the Study:

• To compare the ethnic and racial demographics of patients in prospective chronic rhinosinusitis (CRS) studies with U.S. census data.
• To identify potential disparities in the enrollment of minority populations in CRS clinical trials.
• To evaluate the generalizability of CRS research findings.

Main Methods:

• A systematic review identified U.S.-based CRS clinical trials published between 2010 and 2020.
• Patient demographic data (race and ethnicity) were extracted and pooled.
• Pooled data were compared against national and regional U.S. census demographics.

Main Results:

• Eighty-three studies with 12,027 patients were analyzed.
• White patients constituted 81.67% of the study population, significantly higher than U.S. census data.
• All minority racial and ethnic groups were underrepresented in the analyzed CRS studies (P ≤ .0002).

Conclusions:

• The racial and ethnic makeup of patients in prospective CRS clinical trials significantly differs from the general U.S. population.
• Underrepresentation of minority populations in CRS research raises concerns about the external validity and generalizability of study findings.
• Future research must prioritize enrolling more demographically representative patient cohorts.