Geographic Access Disparities to Clinical Trials in Diabetic Eye Disease in the United States

Soares, Rebecca R.; Parikh, Devayu; Shields, Charlotte N; Peck, Travis; Gopal, Anand; Sharpe, James; Yonekawa, Yoshihiro

doi:10.1016/j.oret.2020.12.006

Cited by 20 publications

(11 citation statements)

References 14 publications

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“…The demographic characteristics of the patients at these sites would not be expected to be entirely reflective of the national population demographic features. Similarly, geographic barriers to accessing these sites and specific inclusion and exclusion criteria may have contributed to our findings. These logistic hurdles may explain the skewness in our analysis despite efforts from investigators to enroll diverse populations in their trials.…”

Section: Discussionmentioning

confidence: 96%

Racial/Ethnic Disparities in Ophthalmology Clinical Trials Resulting in US Food and Drug Administration Drug Approvals From 2000 to 2020

2021

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IMPORTANCE Diverse, representative enrollment in pivotal clinical trials is vital to sufficiently power subgroup analyses and ensure equity and validity of trial results. OBJECTIVE To evaluate the racial/ethnic representation, trends, and disparities in clinical trials leading to US Food and Drug Administration (FDA) ophthalmology drug approvals from 2000 to 2020. DESIGN, SETTING, AND PARTICIPANTSThis cohort study used data from participants in clinical trials of drugs for neovascular age-related macular degeneration (AMD), open-angle glaucoma (OAG), and expanded indications for diabetic retinopathy (DR) from January 1, 2000, to December 31, 2020. Trial data were sourced from FDA reviews, ClinicalTrials.gov, and relevant linked studies. National expected racial/ethnic proportions were sourced from public National Eye Institute prevalence data as well as published rates scaled using US Census Bureau data. MAIN OUTCOMES AND MEASURESThe primary outcome measures were the distribution of and change over time in the racial/ethnic proportion of participants in clinical trials leading to FDA approval of drugs for AMD, OAG, and DR. RESULTSDuring the 20-year period, 31 clinical trials were identified for 13 medications with 18 410 participants. The distribution of trial participants was different from the expected trial distribution for most approvals with regard to race/ethnicity (12 drugs) and sex (10 drugs). Compared with the first decade (2000)(2001)(2002)(2003)(2004)(2005)(2006)(2007)(2008)(2009)(2010), trials conducted in the second decade (2011-2020) showed increases in enrollment of Asian (odds ratio [OR], 2.30; 95% CI, 1.97-2.68; P < .001) and Hispanic or Latinx participants (OR, 1.74; 95% CI, 1.49-2.03; P < .001) for AMD, Asian participants (OR, 2.21; 95% CI, 1.46-3.42; P < .001) for DR, and Black (OR, 1.60; 95% CI, 1.43-1.78; P < .001) and Hispanic or Latinx participants (OR, 10.31; 95% CI, 8.05-13.35; P < .001) for OAG. There was a decrease in Black participants in DR trials (OR, 0.58; 95% CI, 0.42-0.79; P < .001). Based on these trends, the enrollment incidence ratio is expected to worsen by 2050, with overrepresentation of white participants vs underrepresentation of Black and Hispanic or Latinx participants in trials of drugs for AMD (1.08 vs 0.04 vs 0.77), DR (1.83 vs 0.87 vs 0.59), and OAG (1.62 vs 0.90 vs 0.37). CONCLUSIONS AND RELEVANCEIn this cohort study, Black, Hispanic or Latinx, and other non-White participants were underrepresented in clinical trials leading to FDA ophthalmology drug approvals compared with the expected disease burden and racial/ethnic distribution in the US. Although there was meaningful improvement from 2000 to 2020, further efforts to increase minority enrollment in clinical trials seem to be warranted.

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Section: Discussionmentioning

confidence: 96%

Racial/Ethnic Disparities in Ophthalmology Clinical Trials Resulting in US Food and Drug Administration Drug Approvals From 2000 to 2020

2021

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“…Increased access to eye care insurance, low-cost eye care services, and clinical trial sites for disadvantaged populations would be beneficial. 126,127 There is a critical need for educational, motivational, and practical interventions to motivate health care practitioners serving underserved areas to encourage eye examinations among persons at risk for eye diseases, in particular persons with diabetes and hypertension. 44,128,129 For instance, an analysis of the US National Health Interview Survey concluded that older minority adults with less education and lower income were less likely to use Health Internet Technology than White adult users of these specialized health services.…”

Section: Utilizationmentioning

confidence: 99%

Improving Access to Eye Care

Solomon

Shoge²,

Ervin³

et al. 2022

Ophthalmology

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“…Trials designed to ascertain whether the treatment may “work” often achieve internal validity at the expense of uncertainty about generalizability, since the populations enrolled may differ drastically from those seen in clinical practice [ 101 ]. Furthermore, interventional clinical trials for diabetic retinopathy are often conducted in large, urban, tertiary, or quaternary referral centers, and patients residing in areas that are more rural, more impoverished, and from regions outside the Northeast in the United States were likely under-represented in these clinical trials [ 102 ].…”

Section: Prevalence Of Diabetic Retinal Diseasementioning

confidence: 99%

Social Determinants of Health and Impact on Screening, Prevalence, and Management of Diabetic Retinopathy in Adults: A Narrative Review

Patel

Ananthakrishnan

Lin

et al. 2022

JCM

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Diabetic retinal disease (DRD) is the leading cause of blindness among working-aged individuals with diabetes. In the United States, underserved and minority populations are disproportionately affected by diabetic retinopathy and other diabetes-related health outcomes. In this narrative review, we describe racial disparities in the prevalence and screening of diabetic retinopathy, as well as the wide-range of disparities associated with social determinants of health (SDOH), which include socioeconomic status, geography, health-care access, and education.

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Geographic Access Disparities to Clinical Trials in Diabetic Eye Disease in the United States

Cited by 20 publications

References 14 publications

Racial/Ethnic Disparities in Ophthalmology Clinical Trials Resulting in US Food and Drug Administration Drug Approvals From 2000 to 2020

Racial/Ethnic Disparities in Ophthalmology Clinical Trials Resulting in US Food and Drug Administration Drug Approvals From 2000 to 2020

Improving Access to Eye Care

Social Determinants of Health and Impact on Screening, Prevalence, and Management of Diabetic Retinopathy in Adults: A Narrative Review

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