Racial and ethnic disparities in Meniere's disease clinical trials: A systematic review.

Objective: Our study aims to shed light on racial, ethnic, and geographic disparities in phase 2/3 Meniere's disease (MD) clinical trials, with the ultimate goal of enhancing the inclusivity and effectiveness of future MD research.

Methods: We conducted a systematic review of phase 2/3 MD Randomized Controlled Trials (RCTs). Using the search terms "Meniere's Disease" and "Endolymphatic hydrops", we searched ClinicalTrials.gov and PubMed for RCTs taking place from January 2004 to October 2024. Race (self-identification with one or more groups, such as White, Black, Asian, etc.) and ethnicity (Hispanic or non-Hispanic) data were extracted for each RCT.

Results: Twenty-eight RCTs were included in the analysis (2455 total participants). Thirteen of the clinical trials took place in Europe. One took place across Europe and in the United States. Nine RCTs took place in North America. Three RCTs took place in Asia, and two took place in Central or South America. Eight of the studies published comprehensive race data. Across these RCTs, 93.9 % of participants were Caucasian. 2.8 % identified as African American/Black, and 0.8 % identified as Asian. 0.3 % of participants were American Indian/Alaskan Native. 2.2 % identified as other or unspecified. None identified as Native Hawaiian/Pacific Islander.

Discussion: The assessed RCTs demonstrated a demographic spread in line with the presumed increased susceptibility of White individuals to MD. However, less than a third of included studies reported race and ethnicity data. These findings underscore the necessity for future MD RCTs to focus on reporting racial and ethnic diversity to better understand generalizability of results.