Abstract
Background/Objective
To identify geographic and socioeconomic variables associated with residential proximity to Phase 3 ophthalmology clinical trial sites.
Methods
The geographic location of clinical trial sites for Phase 3 clinical trials in ophthalmology was identified using ClinicalTrials.gov. Driving time from each United States (US) census tract centroid to nearest clinical trial site was calculated using real traffic patterns. Travel data were crosslinked to census-tract level public datasets from United States Census Bureau American Community Survey (ACS). Cross-sectional multivariable regression was used to identify associations between census-tract sociodemographic factors and driving time (>60 min) from each census tract centroid to the nearest clinical trial site.
Results
There were 2330 unique clinical trial sites and 71,897 census tracts. Shortest median time was to retina sites [33.7 min (18.7, 70.1 min)]. Longest median time was to neuro-ophthalmology sites [119.8 min (48.7, 240.4 min)]. Driving >60 min was associated with rural tracts [adjusted odds ratio (aOR) 7.60; 95% CI (5.66–10.20), p < 0.0001]; Midwest [aOR 1.84(1.15–2.96), p = 0.01], South [aOR 2.57 (1.38–4.79), p < 0.01], and West [aOR 2.52 (1.52–4.17), p < 0.001] v. Northeast; and tracts with higher visual impairment [aOR 1.07 (1.03–1.10), p < 0.001)]; higher poverty levels [4th v.1st Quartile of population below poverty, aOR 2.26 (1.72–2.98), p < 0.0001]; and lower education levels [high school v. Bachelor’s degree or higher aOR 1.02 (1.00–1.03), p = 0.0072].
Conclusions
There are significant geographic and socioeconomic disparities in access to ophthalmology clinical trial sites for rural, non-Northeastern, poorer, and lower education level census tracts, and for census tracts with higher levels of self-reported visual impairment.
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Data availability
The datasets generated and analysed during the current study are available from ClinicalTrials.gov at https://clinicaltrials.gov/ct2/home and from the U.S. Census Bureau at https://data.census.gov/cedsci/.
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Acknowledgements
The authors acknowledge the support of the Biostatistics Consulting Core, Vickie and Jack Farber Vision Research Center, Wills Eye Hospital.
Funding
J. Arch McNamara Memorial Fund, Philadelphia, Pennsylvania. Wills Eye Foundation, Philadelphia, Pennsylvania. The funding organisations had no role in the design or conduct of this research. Financial Disclosures: Consultant for Alcon (YY), Alimera (YY), Allergan (YY), Genentech (YY); Research consultant for Allergan (AGS); Research support and consultant for Gensight Biologics (MLM).
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Soares, R.R., Huang, C., Sharpe, J. et al. Geographic and socioeconomic access disparities to Phase 3 clinical trials in ophthalmology in the United States. Eye 37, 1822–1828 (2023). https://doi.org/10.1038/s41433-022-02244-7
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DOI: https://doi.org/10.1038/s41433-022-02244-7
