Differential Sex-Based Enrolment into US-Registered Glaucoma Clinical Trials: A Cross-Sectional Study

Area of Science:

• Ophthalmology
• Clinical Trials
• Health Equity

Background:

• Glaucoma affects a significant portion of the population, with varying prevalence across demographic groups.
• Ensuring equitable representation in clinical trials is crucial for generalizability of results.
• Previous studies have highlighted potential underrepresentation of certain groups in medical research.

Purpose of the Study:

• To assess the sex-based enrollment of patients in glaucoma-related randomized controlled trials (RCTs).
• To compare patient enrollment data with the real-world disease burden of glaucoma.
• To identify trends in demographic representation within glaucoma research.

Main Methods:

• A cross-sectional study analyzed glaucoma RCTs registered on ClinicalTrials.gov up to January 2023.
• Included trials were double-masked, completed, and had published results.
• Population-to-prevalence ratios (PPRs) were calculated to assess female enrollment adequacy.

Main Results:

• Out of 1061 records, 177 trials (N=38,475; 56.2% females) were included.
• The pooled female PPR was 1.05 (95% CI 1.02, 1.08), indicating sufficient enrollment.
• Equitable female enrollment was observed across most study characteristics, with pre-1997 studies showing indeterminate data.

Conclusions:

• US-registered glaucoma trials demonstrate acceptable female participant enrollment relative to disease burden.
• Findings suggest progress towards equitable demographic representation in glaucoma research.
• Continued efforts are recommended to ensure diverse enrollment in future clinical trials.