(0249) Racial and Ethnic Disparities in Phase 2 and 3 Ménière's Disease Clinical Trials

Introduction: Ménière's disease (MD) likely develops as a result of multiple environmental and genetic factors. Recent literature suggests the primarily White demographics of MD is better explained by differential susceptibility rather than selection bias in patients presenting for treatment. Our study aims to investigate the racial/ethnic recruitment and geographic diversity of clinical trials on MD, with the goal of enhancing the inclusivity and effectiveness of future research.

Methods: An examination of phase 2/3 Randomized Controlled Trials (RCTs) on Meniere's Disease therapies was conducted in January 2024. ClinicalTrials.gov was searched for 'Meniere's Disease’ and studies were cross-referenced with associated publications identified on PubMed (2009-2024). Race, ethnicity, and geographical distribution data were extracted.

Results: In total, 19 RCTs including 1,882 participants were included in the analysis. The trial sites were Europe (N = 8, 31%), North America (N = 16, 61%), Asia (N = 1, 4%), and South America (N = 1, 4%). About half of RCTs included race data (N = 11) and ethnicity data (N = 10). Ethnicity was limited to identification of Hispanic origin. Of studies including race data, female patients constituted 60% (N = 1,013). White participants (N = 1,504, 82.5%) were the predominant group, followed by American Indian or Alaskan Native (N = 86, 5%), Asian (N = 35, 2.5%), African American (N = 25, 2%). Additionally, 51 participants (3.5%) identified as Hispanic.

Conclusions: Current clinical trials on MD represent demographics that are in line with the presumed susceptibility differential. Racial and ethnic minorities appear to be recruited at a rate similar to what would be expected with development of the disease. However, only half of included studies reported race data, and ethnicity data is minimally reported. Furthermore, there is a global disparity in enrollment and participation from non-Western countries. These findings underscore the necessity to for future MD clinical trials to focus on reporting racial and ethnic diversity to better understand generalizability of results.