June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Racial/Ethnic Diversity in the US Ophthalmology Clinical Trials
Author Affiliations & Notes
  • Michael Wang
    California Northstate University College of Medicine, Elk Grove, California, United States
  • Fateme Montazeri
    Department of Ophthalmology & Vision Science, Tschannen Eye Institute, University of California Davis, Sacramento, California, United States
  • Abhijith Atkuru
    Eastern Virginia Medical School, Norfolk, Virginia, United States
  • Marcela Maria Estrada
    Department of Ophthalmology & Vision Science, Tschannen Eye Institute, University of California Davis, Sacramento, California, United States
  • Yin Allison Liu
    Department of Ophthalmology & Vision Science, Tschannen Eye Institute, University of California Davis, Sacramento, California, United States
    Departments of Neurology and Neurosurgery, University of California Davis, Sacramento, California, United States
  • Parisa Emami-Naeini
    Department of Ophthalmology & Vision Science, Tschannen Eye Institute, University of California Davis, Sacramento, California, United States
  • Footnotes
    Commercial Relationships   Michael Wang None; Fateme Montazeri None; Abhijith Atkuru None; Marcela Estrada None; Yin Liu None; Parisa Emami-Naeini Eyepoint and Bausch+Lomb, Code C (Consultant/Contractor)
  • Footnotes
    Support  This work is supported by the UC Davis Eye Center. Abhijith Atkuru was supported by training funds from the J. William Kohl Summer Scholarship for Medical Students. The funding organizations did not play any role in the design or conduct of this retrospective study; the collection, management, analysis, or interpretation of data; or the preparation, review, approval, submission decision of the manuscript. The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding agencies.
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 3033. doi:
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    • Get Citation

      Michael Wang, Fateme Montazeri, Abhijith Atkuru, Marcela Maria Estrada, Yin Allison Liu, Parisa Emami-Naeini; Racial/Ethnic Diversity in the US Ophthalmology Clinical Trials. Invest. Ophthalmol. Vis. Sci. 2023;64(8):3033.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Equitable inclusion and representation of racial/ethnic groups in clinical trials are important in producing generalizable data. Disparities and mismatches between clinical trial participants and the general population result in selection bias and inaccurate results in these studies. The purpose of our study is to investigate the status of racial/ethnic disparities in the ophthalmology clinical trials conducted in the United States (US).

Methods : In this retrospective cross-sectional study, we analyzed the demographics of completed phases 2/3, 3, and 4 US ophthalmology clinical trials in the ClincialTrials.gov database. We calculated proportional enrollments of racial/ethnic groups in the trials and compared them to the 2010 US Census data. Using regression analysis, we examined the association between various trial features (i.e., phase of the trial, starting year, funding source, and primary condition) and the rate of disclosing demographic data and inclusion of racial/ethnic minorities.

Results : Among the total of 653 completed trials, racial/ethnic background were reported in 128 (43.6%) including 37,031 participants. Compared to the US census data, Whites were enrolled more commonly (median 76.6%, Inter quartile range (IQR) 69.0-84.0%) and minority groups, including Asians (median 1.8%, IQR 0.4-3.8%), Hispanics (median 12.5%, IQR 6.3-17.5%), and other group (median 1.7%, IQR 0.2-4.3%) were underrepresented (p<0.001). Interestingly, enrollment of Blacks[FM1] [PEN2] was comparable to their population estimates (median 12.4%, IQR 6.2-20.8, p=0.44). Rate of reporting race/ethnicity data was higher among earlier phase (2/3 and 3) trials and increased over time (average increase of 11.4% annually; p<0.001). Moreover, glaucoma and pediatric trials had the highest rate of reporting demographics data[FM3] [PEN4] (p≤0.001). Additionally, glaucoma trials had greater enrollment of Black individuals (p=0.001).

Conclusions : Racial/ethnic disparities in clinical trials enrollment can skew the results of these studies and compromise generalizability of findings. Ophthalmology trials suffer from significant underrepresentation of minorities. More efforts are needed to reduce disparities and ensure unbiased discoveries.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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