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  • Ethnic Disparities in Clinical Trials of Ophthalmic Drugs

    By Jean Shaw
    Selected and Reviewed By: Neil M. Bressler, MD, and Deputy Editors
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    Journal Highlights

    JAMA Ophthalmology, June 2021

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    Berkowitz et al. evaluated the ethnic representation, trends, and disparities in clinical trials leading to FDA ophthal­mology drug approvals from 2000 to 2020. They found that Black, Hispanic, and other non-White populations were underrepresented in these studies, although some improvement occurred during the 20-year time frame.

    For this cohort study, the research­ers used data from participants in 31 clinical trials of drugs for neovascular age-related macular degeneration (AMD; n = 10), open-angle glaucoma (OAG; n = 16), and expanded indica­tions for diabetic retinopathy (DR; n = 5). All told, 13 drugs were studied.

    National expected ethnic propor­tions were sourced from U.S. Census Bureau and NEI data. The primary out­come measures were the distribution of and change over time in the ethnic proportion of participants in clinical trials leading to FDA approval of drugs for the three disease categories.

    The 31 clinical trials involved 18,410 participants. With regard to overall participation, disparity analyses showed overrepresentation of White partici­pants and underrepresentation of Black and Hispanic participants compared with the expected disease burden and ethnic distribution in the United States. These disparities did begin to narrow over time, with increased enrollmentof Asian participants in AMD and DR studies, increased participation of Hispanics in AMD and OAG trials, and increased enrollment of Black patients in OAG studies. However, there was no change in enrollment of Black partici­pants in AMD studies and a decrease in Black participants in DR trials.

    The researchers noted that category reporting by ethnicity was inconsistent and variable across the studies evaluat­ed, and they called for comprehensive and standardized reporting of demographic characteristics in clinical trials.

    Above all, they said, investigators should focus on diverse, representative enrollment in pivotal studies. (Also see related commentary by Päivi H. Miskala, MSPH, PhD, and Senaka A. Peter, MPH, in the same issue.)

    The original article can be found here.