Abstract
Purpose :
To assess the status of reporting and representation of racial/ethnic groups in pivotal trials leading to US Food and Drug Administration (FDA) approval and CE marking in Europe of glaucoma devices between 2000 and 2021.
Methods :
Ethnicity reporting, enrolment incidence disparity (EID) and enrolment incidence ratio (EIR) were calculated for each pivotal glaucoma device study. Descriptive statistics, Fisher’s exact, and χ2 tests were used to analyse the data. Proportions and odds ratios (OR) with 95% confidence interval (CI) were reported.
Results :
In 65 trials leading to FDA and EU glaucoma device approvals and EU over the past 20 years, ethnicity was reported in only 24 (36.4%) trials. There was no statistically significant difference in ethnicity reporting between studies published 2000-2009 44.4% and 2010-2021 34.0% [odds ratio 1.55 95% 0.51 – 4.70 (p=0.44)], according to trial size (p=0.12), trial randomisation (p=0.39). Ethnicity was reported in 11% of 510k and 100% of PMA approved devices 95% CI 0 – 0.43 (p=0.01) FDA clinical summary reports.
EID for each ethnic category was -0.11 (95% CI -1.9 to -0.03) Afro-Caribbean, -0.28 (-0.40 to -0.17) Asian, 0.37 (0.23 to 0.50) Caucasian and 0.03 (-0.08 to 0.14) Others. EIR for each ethnic category was 0.56 (0.23 to 0.89) Afro-Caribbean, 0.31 (0.04 to 0.59) Asian, 2.62 (2.01 to 3.23) Caucasian and 1.29 (0.19 to 2.39) Others.
Caucasians were overrepresented by 37% of expected proportion, Afro-Caribbeans and Asians were underrepresented by 11% and 28% respectively in these trials relative to their proportion among the global glaucoma population.
Conclusions :
Suboptimal ethnicity reporting and enrolment (especially under reporting of minority ethnic groups) occurs regularly in landmark glaucoma trials and there is more marked under reporting in pivotal studies of devices approved via 510k route. Increased efforts are needed to enhance minority representation and eliminate these disparities. Enhanced minority engagement is warranted in trials to ensure the validity of results and reliable benefits to all.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.