Abstract
Purpose :
It is important that randomized control trials (RCTs) represent real world patient populations. The purpose of this study was to compare the distribution of race in retinal vein occluion (RVO) RCTs to the United States population.
Methods :
We performed a cross-sectional study of the racial demographics of 8 RCTs for RVO and compared them to the United States 2019 census data. The number and percent of White, Black, Hispanic, Asian, American Indian/Alaska Native, Native Hawaiian/Pacific Islander participants was recorded. Chi-square test and one-sample z-test were used. Over- or underrepresentation of each race in every RTC was denoted.
Results :
In the 8 RVO RCTs the white patient cohort was overrepresented in 5 RCTs. The difference was not statistically significant in 3. Of note, one study decribed the study participants only as white and non-white. The black patient cohort was underrepresented in 5, and not statistically different in 2. The Hispanic patient cohort was underrepresented in 6 and not statistically different in 1. The Asian patient cohort was overrepresented in 2 RCT, underrepresented in 1, and not statistically different in 4. The American Indian/Alaska Native and Hawaiian/Pacific Islander patient cohort was underrepresented in 6 RCT and not statistically different in 1.
Conclusions :
The current study finds that that racial demographic data of subjects in majority of randomized control trials for treatment of retinal vein occlusion does not reflect that of the United States population, according to the 2019 US Census. Subjects identified as white tend to be overrepresented in randomized control trials. More efforts should be made to recruit underrepresented minorities to improve trial external validity and better serve these subpopulations.
This is a 2021 ARVO Annual Meeting abstract.