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Racial and Ethnic Diversity in the US Ophthalmology Clinical Trials
Introduction: Equitable inclusion and representation of racial/ethnic groups in clinical trials is important in producing generalizable data. Disparities and mismatches between clinical trial participants trials’ enrollees and general population result in selection bias and distortion of information generated by these studies. The purpose of current study was to investigate the status of racial/ethnic disparities in the ophthalmology clinical trials conducted in the United States. Methods: In this retrospective cross-sectional study, we utilized demographic reports of completed phases 2/3, 3, and 4 ophthalmology clinical trials conducted in the US, using the ClincialTrials.gov database. We calculated proportional enrollments of racial/ethnic groups in the trials and compared them to the 2010 US Census data as the reference population. Using regression analysis, we examined the association between various trial features (i.e., phase of the trial, starting year, funding source, and primary condition) and rate of disclosing demographics data and inclusion of racial/ethnic minorities. Results: Among the total of 653 completed trials, racial/ethnic background were reported in 128 trials (43.6% of the studies, comprising 3 7031 participants). Compared to the US census data, White individuals were enrolled more commonly (median 76.6%, Inter quartile range (IQR) 69.0-84.0%) and minority groups, including Asians (median 1.8%, IQR 0.4-3.8%), Hispanics (median 12.5%, IQR 6.3-17.5%), and other group (median 1.7%, IQR 0.2-4.3%) were underrepresented (p<.001). Interestingly, enrollment of African-American individuals was comparable to their population estimates (median 12.4%, IQR 6.2-20.8, p=0.44). Rate of reporting race/ethnicity data was higher among earlier phase (2/3 and 3) trials and increased over time (average increase of 11.4% annually; p<0.001). Additionally, glaucoma trials had greater enrollment of Black individuals (p=0.001). Conclusion: Racial/ethnic disparities in clinical trials enrollment can skew the results of these studies and compromise generalizability of findings. Ophthalmology trials suffer from significant underrepresentation of minorities. More efforts are needed to reduce disparities and ensure unbiased discoveries.