Sociodemographic disparities in ophthalmological clinical trials

Luis Filipe Nakayama; William Greig Mitchell; Skyler Shapiro; Alvina Pauline D Santiago; Warachaya Phanphruk; Khumbo Kalua; Leo Anthony Celi; Caio Vinicius Saito Regatieri

doi:10.1136/bmjophth-2022-001175

Sociodemographic disparities in ophthalmological clinical trials

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

Authors

Luis Filipe Nakayama^{1

2}, William Greig Mitchell³, Skyler Shapiro^{4

5}, Alvina Pauline D Santiago⁶, Warachaya Phanphruk⁷, Khumbo Kalua⁸, Leo Anthony Celi^{4

9}, Caio Vinicius Saito Regatieri²

Affiliations

¹ Laboratory for Computational Physiology, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA luisnaka@mit.edu.
² Ophthalmology, Federal University of Sao Paulo, Sao Paulo, Brazil.
³ Ophthalmology, The Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia.
⁴ Laboratory for Computational Physiology, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
⁵ Cornell University, Ithaca, New York, USA.
⁶ Department of Ophthalmology and Visual Sciences, Philippine General Hospital, Manila, Metro Manila, Philippines.
⁷ Ophthalmology, Khon Kaen University, Nai Mueang, Khon Kaen, Thailand.
⁸ Ophthalmology, Kamuzu University of Health Sciences, Blantyre, Southern Region, Malawi.
⁹ Biostatistics, Harvard University T.H. Chan School of Public Health, Boston, Massachusetts, USA.

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.

Publication types

Review

MeSH terms

Cataract*
Ethnicity
Glaucoma* / diagnosis
Humans
Minority Groups
Ophthalmology*
United States / epidemiology