Sociodemographic disparities in ophthalmological clinical trials
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Author(s)
Nakayama, Luis Filipe
Mitchell, William Greig
Shapiro, Skyler
Santiago, Alvina Pauline D.
Phanphruk, Warachaya
Kalua, Khumbo
Celi, Leo Anthony
Regatieri, Caio Vinicius Saito
Date Issued
February 2023
Publisher
BMJ
Citation
Nakayama, Luis Filipe, Mitchell, William Greig, Shapiro, Skyler, Santiago, Alvina Pauline D., Phanphruk, Warachaya et al. 2023. "Sociodemographic disparities in ophthalmological clinical trials." 8 (1).
Version
Final published version
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.
Subjects
Ophthalmology
MIT Department
Harvard--MIT Program in Health Sciences and Technology. Laboratory for Computational Physiology
Terms of Use
Creative Commons Attribution NonCommercial License 4.0
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DOI of Published Version
https://doi.org/10.1136/bmjophth-2022-001175
