Disparities in racial, ethnic, and gender composition found in retinal vein occlusion clinical trials

There are significant disparities in the racial, ethnic, and gender composition of clinical trial cohorts for retinal vein occlusion (RVO) with macular edema (ME) when compared to the broader population receiving treatment for this condition, according to a study presented at AAO 2023. Specifically, the study found that Asian and White individuals, as well as men, were overrepresented in these trials, while Black and Hispanic populations were underrepresented.

The study examined cohorts from RVO-ME clinical trials and analyzed their composition based on race, ethnicity, and gender. The primary metric utilized was the enrollment fraction, calculated by dividing the number of trial participants by the reference sample size of RVO patients receiving ME treatment, as per data from the IRIS Registry.

The results indicated notable disparities in enrollment fractions across different demographic groups. Compared to the reference sample size among White participants, lower enrollment fractions were observed in Black and Hispanic populations. Conversely, a higher enrollment fraction was noted among Asian participants. Additionally, the study found a higher likelihood of men enrolling in these clinical trials compared to women.

These findings highlight a critical issue in clinical trial representation, potentially impacting the generalizability of study outcomes. The overrepresentation of certain racial, ethnic, and gender groups in RVO-ME trials underscores the need for more inclusive recruitment strategies to ensure that trial results are applicable to a broader patient population.

Reference
Bowe TS, et al. Racial, Ethnic and Gender Disparities in RVO Clinical Trials. Presented at: AAO 2023.