Ethnoracial Representation in U.S. Clinical Trials for Retinal Vein Occlusion.

PURPOSE Retinal vein occlusion (RVO) is the second most common cause of vision loss from retinal vascular disease. Clinical trials often lack adequate representation of minority groups, limiting the external validity and equity of trial results. We aimed to characterize the evolution of ethnoracial demographic reporting, changes in the racial & ethnic composition of RVO trial participants, and correlations with trial sponsor and collaborator types. DESIGN Retrospective trend study SUBJECTS: Participants, sponsors, and collaborators in RVO clinical trials based in the United States (U.S.) METHODS: We assessed the ethnoracial distribution of patients and sponsors & collaborators in RVO clinical trials. Trial data was sourced from ClinicalTrials.gov and compared with 2022 U.S. Census Bureau data. MAIN OUTCOME MEASURES Change in ethnoracial reporting and representation, and comparison of representation within RVO clinical trials with 2022 U.S. Census demographics. RESULTS Racial data was not documented for all 6 (12.2%) trials completed between 2008 and 2011. There was increased ethnoracial reporting between January 2012 to June 2017 (n = 6/29, 20.7%) vs July 2017 to December 2022 (n = 13/14, 92.9%) (OR 49.8; 95% CI: 5.39-460.47; p<0.0001). The proportion of Asian participants increased from 4.2% to 15.9% (OR 4.37; 95% CI 2.49-8.37; p<0.0001), and Black participants rose from 6.1% to 20.7% (OR 4.03; 95% CI 2.51-6.85; p<0.0001). Conversely, White participants decreased from 73.8% to 56.0% (OR 0.45, 95% CI 0.34-0.59; p<0.0001), and Hispanic/Latino participants decreased from 13.1% to 5.4% (OR 0.38; 95% CI 0.26-0.56; p<0.0001). Compared to the 2022 US Census data, the ethnoracial distribution of the total U.S. population is significantly different than the total enrollment in RVO clinical trials (p<0.0001). Government and academic involvement were correlated with less White and more Black representation respectively (p≤0.01). CONCLUSIONS From 2008 to 2022, there has been a notable increase in the documentation of racial and ethnic demographics in RVO clinical trials. Although the recruitment of Asian and Black patients has increased, the Hispanic population remains significantly underrepresented among RVO trial participants, highlighting the need for greater inclusivity in enrollment.