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Review
. 2023 Feb;8(1):e001175.
doi: 10.1136/bmjophth-2022-001175.

Sociodemographic disparities in ophthalmological clinical trials

Luis Filipe Nakayama  1   2 , William Greig Mitchell  3 , Skyler Shapiro  4   5 , Alvina Pauline D Santiago  6 , Warachaya Phanphruk  7 , Khumbo Kalua  8 , Leo Anthony Celi  4   9 , Caio Vinicius Saito Regatieri  2
Affiliations
Review

Sociodemographic disparities in ophthalmological clinical trials

Luis Filipe Nakayama et al. BMJ Open Ophthalmol. 2023 Feb.

Abstract

Introduction: In ophthalmology, clinical trials (CTs) guide the treatment of diseases such as diabetic retinopathy, myopia, age-related macular degeneration, glaucoma and keratoconus with distinct presentations, pathological characteristics and responses to treatment in minority populations.Reporting gender and race and ethnicity in healthcare studies is currently recommended by National Institutes of Health (NIH) and Food and Drug Administration (FDA) guidelines to ensure representativeness and generalisability; however, CT results that include this information have been limited in the past 30 years.The objective of this review is to analyse the sociodemographic disparities in ophthalmological phases III and IV CT based on publicly available data.

Methods: This study included phases III and IV complete ophthalmological CT available from clinicaltrials.org, and describes the country distribution, race and ethnicity description and gender, and funding characteristics.

Results: After a screening process, we included 654 CTs, with findings that corroborate the previous CT reviews' findings that most ophthalmological participants are white and from high-income countries. A description of race and ethnicity is reported in 37.1% of studies but less frequently included within the most studied ophthalmological specialty area (cornea, retina, glaucoma and cataracts). The incidence of race and ethnicity reporting has improved during the past 7 years.

Discussion: Although NIH and FDA promote guidelines to improve generalisability in healthcare studies, the inclusion of race and ethnicity in publications and diverse participants in ophthalmological CT is still limited. Actions from the research community and related stakeholders are necessary to increase representativeness and guarantee generalisability in ophthalmological research results to optimise care and reduce related healthcare disparities.

Keywords: Clinical Trial; Epidemiology; Public health.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Flow diagram of inclusion and exclusion.
Figure 2
Figure 2
Ophthalmologic specialty distribution and percentage with race description.
Figure 3
Figure 3
Percentage of ophthalmologic clinical trials with race description by year and the number of studies (n).
Figure 4
Figure 4
Clinical Trials funding characteristics and percentage with race description. NIH, National Institutes of Health.
See this image and copyright information in PMC

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