Diversity in Enrollment to Clinical Trials for Cataract Medicine and Surgery: A Meta-Analysis

Theme: Equity, diversity and inclusion
What: Equity, diversity and inclusion
Part of: EDI Symposium II: EDI in Action / de diversité, d’équité et d’inclusion II : L’EDI en action
When: 5/31/2024, 02:00 PM - 03:30 PM
Where: Room | Salle 716 B

Abstract

Purpose: To investigate sex, racial, and ethnic disparities in patient enrollment across cataract trials registered in the United States (US).

Study Design: Cross-sectional study of participants enrolled in high-quality (reduced risk of bias), US-registered (on clinicaltrials.gov), cataract-related randomized controlled trials (RCTs). RCTs must have been completed, employed double or greater masking, and have published results through the registry or a scholarly journal.

Methods: Trial (study sponsor country, study site location, trial initiation year, study phase, and study masking) and demographic data (sex, race, and ethnicity according to US reporting guidelines) were collected from clinicaltrials.gov study records, and where available, their correspdoning journal publication. The Global Burden of Disease (GBD) database provided sex-based cataract disease burdens, calibrated to each study's initation year and countries of study. For each study, we calculated a participation-to-prevalence ratios (PPRs), given by the enrollment of females in a given study divided by its expected female enrollment according to their disease burden reported from the GBD database. Pooled PPR with 95% confidence intervals (CI) were then calculated for female sex, with a value between 0.8 and 1.2 constituting sufficient study enrollment. Kruskal-Wallis tests (alpha = 0.05) with subsequent post-hoc comparisons were used to evaluate demographic representations stratified by trial characteristics.

Results: From 864 records, we identified 100 clinical trials (N=67 874), of which 97 (N=67 697) reported sex demographics with a pooled female PPR of 0.89, 95%CI [0.85,0.94]. The PPR for females was significantly more favorable for studies published between 2011-2020 than before 2001, and in studies investigating devices or procedures over drug therapies. Of the 67 697 total participants, the absolute female enrollment was 19 062 (28.16%) and their absolute enrollment was significantly higher in lesser masked studies, lesser phase studies, studies with US sites and sponsors, and drug trials. Ethnicity and race were reported in 9 (N= 1 792) and 26 trials (N= 23 181), respectively. Among trials that reported race, most were Caucasian (N=19 574; 84.44%). For both race and ethnicity, there were predominately no significant differences between sub-levels of various trial characteristics. However, Black or African American and American Indian/Alaskan Native participants were enrolled significantly more often in drug over device and procedure trials.

Conclusions: High-quality, US-registered, cataract trials enrolled acceptable proportions of females. However, the absolute number of female and racialized participants was low. Race and ethnicity were underreported. Disparity trends predominately held across secondary variables. To promote generalizability, future trials should pursue equitable demographic enrollment.

Presenter(s)

Presenting Author: Brendan Tao

Additional Author(s):

Manvis Xia, University of British Columbia

Jim Xie, McMaster University

Sahand Marzban, University of Western Ontario

Amir Vosoughi, University of Manitoba

Nina Ahuja, McMaster University

Guillermo Rocha, McGill University

---