Researchers included 98 phase 2-4 uveitis trials during the time period from clinicaltrials.gov.
The study assessed the institutional, geographic, and temporal disparities in US uveitis clinical trial from 2000 to 2023. Image credit: AdobeStock/photon_photo
A recent study has found an underrepresentation of uveitis in clinical trials conducted in the last 2 decades. In assessing the institutional, geographic, and temporal disparities in US uveitis clinical trial from 2000 to 2023, study authors noted that the disparities in trial access that was demonstrated can exacerbates inequities affecting underserved communities.1
The study authors were led by Jainam Shah of Albert Einstein College of Medicine in the Bronx, New York.1
Researchers identified phase 2-4 uveitis trials during the time period from clinicaltrials.gov, with trials without US sites or multicenter trials lacking site-level data excluded from the study. Categories for the trials consisted of sponsorship (public, private, and unknown), institution (academic, public, private, unknown), geography (south, west, midwest, northeast), and anatomy (anterior, intermediate, posterior, uveitic macular edema, or unspecified/general uveitis). Statistical significance was set at p < 0.05, and adjusted odds ratios (aORs) with 95% confidence intervals (CIs) were calculated, with sponsorship and institution categories analyzed separately and enrollment sizes compared between institutions. Private sponsorship ultimately accounted for over 55% of trials, followed by public (27.6%) and unknown (17.3%), with posterior uveitis most studied at almost 42%.1
Results from the research that included 98 trials found that private trials increased from 28.8% (2000–2011) to 58.6% (2012–2023), while public trials declined from 40.9% to 22.4% (p = 0.006). Additionally, uveitis trials rose from 22.7% to 51.7% (P = 0.002). On average, private trials enrolling more participants (median: 92, interquartile range 65–110) than public (54; 40–74), academic (36; 26–50), and unknown trials (40; 32–68) (P = 0.004). Notably, trials from 2012 through 2023 were more likely to be privately sponsored (2.84; 1.05–7.68; P = 0.039).1
“Although these trials offer broader enrollment, their concentration in the South/West and private sponsorship limit access for patients in the Midwest, Northeast, and public systems. Academic studies on neglected subtypes like intermediate uveitis or macular edema, remain underrepresented,” the study authors stated.
Additionally, a surge in posterior uveitis studies were observed in 2016 following the US Food and Drug Administration’s approval in adalimumab.1
“These findings align with concerns that uveitis care and by extension, access to trials remains concentrated in resource-rich centers, with geographic barriers disproportionately affecting underserved populations,” the study authors stated, noting that 36.7% of Americans live more than an hour from a uveitis specialist, with these populations having higher rates of poverty and public insurance. “Moreover, fewer than 200 uveitis specialists are active nationally, often lacking support staff or institutional infrastructure to run trials. Public investment and academic incentives are necessary to address these inequities and promote equitable innovation in ophthalmology.”
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