June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Racial and ethnic distribution among Age-related Macular Degeneration clinical trial participants in the US from 2002-2021
Author Affiliations & Notes
  • Mouayad Masalkhi
    School of Medicine, University College Dublin, Dublin, Dublin, Ireland
  • Amy J Yu
    University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States
  • Ethan Waisberg
    School of Medicine, University College Dublin, Dublin, Dublin, Ireland
  • Jay Chhablani
    UPMC, Pittsburgh, Pennsylvania, United States
    University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States
  • Footnotes
    Commercial Relationships   Mouayad Masalkhi None; Amy Yu None; Ethan Waisberg None; Jay Chhablani Salutaris, Allergan, Novartis, Erasca, Code C (Consultant/Contractor)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2023, Vol.64, OD13. doi:
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    • Get Citation

      Mouayad Masalkhi, Amy J Yu, Ethan Waisberg, Jay Chhablani; Racial and ethnic distribution among Age-related Macular Degeneration clinical trial participants in the US from 2002-2021. Invest. Ophthalmol. Vis. Sci. 2023;64(8):OD13.

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

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Abstract

Purpose : The goal of this study was to look at differences in race and ethnicity among people who took part in AMD clinical trials in the United States. This is in order to highlight any existing misrepresentation of certain racial and ethnic groups, and report on the trajectory of participant diversity in clinical trials over 2 decades.

Methods : This was a cross-sectional, retrospective study that looked at the racial and ethnic distribution of people who took part in age-related macular degeneration (AMD) clinical trials in the US from 2002 to 2021. Interventional studies (clinical trials) were screened for AMD, US trial location, study completion, and patient enrollment greater than 50 from ClinicalTrials.gov. Descriptive statistics and χ2 tests were used for data analysis. Proportions and odds ratios were also reported

Results : Out of the total 109 AMD trials, 60 (55.0%) reported at least one race as a baseline characteristic, while 49 (45.0%) did not. There was an increase in race reporting from January 2002 to December 2011 (17 [30.4%] trials) vs. January 2012 to December 2021 (43 [81.1%] trials) (OR = 9.86; 95% CI: 4.04, 24.10). In the 60 AMD trials that included racial data, there were a total of 15684 White participants (83.26%), 1705 Black (9.05%), 1268 Asian (6.73%), 70 American Indian/Alaska Native (0.37%), 33 Native Hawaiian/Other Pacific Islander (0.18%), 77 of more than one race (0.41%), and 1720 Hispanic (8.6%).
The proportion of Asian patients enrolled increased from 2.2% to 8.5% (OR = 4.17; 95% CI: 0.66, 1.94), and the proportion of enrolled Hispanic patients increased from 7.0% to 11.2% (OR = 1.67; 95% CI: 1.48, 1.89) across the 2 decades. Notably, there was a drop in the proportion of White patients enrolled from 89.7% to 80.7% (OR=0.48; 95% CI=0.43, 0.53), and a rise in the proportion of Black participants enrolled from 7.1% to 9.8% (OR=1.43; 95% CI=1.27, 1.61).

Conclusions :
Racial reporting in clinical trials for AMD has continued to rise during the last two decades. Black, Asian, and Hispanic patient enrolment has grown, although US Census data show that the Hispanic population is still disproportionately underrepresented among AMD clinical trial participants

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

 

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