In this issue of JAMA Ophthalmology, Berkowitz et al1 present the racial and ethnic distribution of participants enrolled in clinical trials that led to US Food and Drug Administration (FDA) ophthalmology product approvals from 2000 to 2020 compared with the expected disease prevalence and racial/ethnic distribution in the US population. The authors reported that there has been a meaningful improvement in the enrollment of Asian, Hispanic or Latinx, and Black participants over the reported time frame, but their analysis suggests that underrepresentation of these patient populations in pivotal clinical trials persists. Similar findings of underrepresentation of racial and ethnic participants in ophthalmology trials of new molecular entities have also been reported by Birnbaum.2 This is emblematic of the disparity identified across clinical trials in various therapeutic areas as noted by Berkowitz et al.1 According to the US Census, the US will become a more racially and ethnically pluralistic society with less than 50% of the US population projected to be non-Hispanic White by 2044.3 If clinical trials continue to lack representation of diverse patient populations, the robustness and generalizability of the research findings to those populations may be limited.
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Miskala PH, Peter SA. Critical Importance of Diversity and Inclusion in Medical Product Development. JAMA Ophthalmol. Published online April 22, 2021. doi:10.1001/jamaophthalmol.2021.0855
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