A recent study published in JAMA Ophthalmology has revealed significant racial and ethnic disparities in the enrollment of pediatric ophthalmology clinical studies. The cross-sectional analysis of 41 clinical studies conducted by the Pediatric Eye Disease Investigator Group (PEDIG) between 1997 and 2022 found that Hispanic, Black, and Asian children were consistently underrepresented compared to their proportion in the U.S. population.
The study, which included data from 11,658 participants, aimed to evaluate the representation of different racial, ethnic, and sex groups in PEDIG clinical studies relative to the 2010 U.S. Census pediatric population. The researchers analyzed participant demographics collected from peer-reviewed publications, patient-enrollment datasets, and ClinicalTrials.gov.
The results indicated that White participants were overrepresented (enrollment-census difference [ECD], 0.19; 95% CI, 0.10-0.28; P < .001), while Black (ECD, −0.07; 95% CI, −0.10 to −0.03; P < .001), Asian (ECD, −0.03; 95% CI, −0.04 to −0.02; P < .001), and Hispanic participants (ECD, −0.09; 95% CI, −0.13 to −0.05; P < .001) were underrepresented. Female participants were represented proportionately (ECD, 0.004; 95% CI, −0.036 to 0.045; P = .21).
Temporal Trends in Enrollment
Interestingly, the study also identified temporal trends in enrollment patterns. White and Asian participant enrollment showed a decreasing trend from 1997 to 2022 (White: compound annual growth rate [CAGR], −1.5%; 95% CI, −2.3% to −0.6%; Asian: CAGR, −1.7%; 95% CI, −2.0% to −1.4%), while Hispanic participant enrollment demonstrated an increasing trend (CAGR, 7.2%; 95% CI, 3.7%-10.7%).
Implications for Pediatric Ophthalmology Research
The authors of the study emphasize the importance of addressing these disparities to ensure that clinical research is representative of the diverse pediatric population. They suggest that changes in PEDIG enrollment practices have contributed to a decrease in these disparities and may serve as a model for facilitating more diverse clinical study enrollment.
"This study demonstrates an opportunity to advocate for increased enrollment of underrepresented groups in pediatric ophthalmology clinical studies," the authors concluded. The findings underscore the need for targeted efforts to improve the recruitment and retention of minority participants in clinical trials, ultimately leading to more equitable and effective healthcare outcomes for all children.
