Representative and diverse enrollment in pivotal clinical trials is crucial for adequately powering subgroup analysis and ensuring credibility, equity, and validity of the results. This study aims to analyze the trends and disparities in racial/ethnic representations leading to USA FDA drug approvals.
This cohort study included 31 clinical trials and data on 18,410 participants with the following conditions: open-angle glaucoma (OAG), neovascular age-related macular degeneration (AMD), and diabetic retinopathy (DR). The primary endpoints of the study were the distribution of and change over time in the racial or ethnic proportion of participants.
The trials included in this study were conducted during 2000-2020. The findings suggested that trials conducted in 2010-2020 saw an increased enrollment of Asian and Hispanic/Latin participants compared to the trials conducted in 2000-2010. The findings further showed that there was a decrease in the number of Black participants in DR trials. Researchers predicted that based on these trends, the enrollment incidence ratio could worsen by 2050, with the overrepresentation of white participants and the underrepresentation of Asian, Black, and Hispanic participants.
The research concluded that non-white participants, including Black, Asian, and Hispanic, were underrepresented in ophthalmology clinical trials that received USA FDA approval.