Geographic and socioeconomic access disparities to Phase 3 clinical trials in ophthalmology in the United States | Eye – Nature.com


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To identify geographic and socioeconomic variables associated with residential proximity to Phase 3 ophthalmology clinical trial sites.
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.
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].
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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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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The authors acknowledge the support of the Biostatistics Consulting Core, Vickie and Jack Farber Vision Research Center, Wills Eye Hospital.
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).
Retina Service, Wills Eye Hospital, Mid Atlantic Retina, Thomas Jefferson University, Philadelphia, PA, USA
Rebecca Russ Soares, Charles Huang, Lucy Cobbs, Anand Gopal, Winnie Rao, Annika Samuelson, Devayu Parikh, Robert Bailey, James P. Dunn, Mark L. Moster, Julia A. Haller & Yoshihiro Yonekawa
Biostatistics Consulting Core, Vickie and Jack Farber Vision Research Center, Wills Eye Hospital, Philadelphia, PA, USA
James Sharpe & Qiang Zhang
Uveitis Service, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA
James P. Dunn
Pediatric Ophthalmology Service, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA
Jade Minor
Neuroophthalmology Service, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA
Mark L. Moster
Oculoplastics Service, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA
Robert B. Penne
Ocular Oncology Service, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA
Carol Shields
Glaucoma Service, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA
Aakriti G. Shukla
Cornea Service, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA
Zeba Syed
Cataract & Primary Eye Care Service, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA
Douglas Wisner
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RRS- Research design, data acquisition/research execution, data analysis, manuscript preparation CH- Research design, data acquisition/research execution, data analysis JS- Data analysis, manuscript preparation LC- Research design, manuscript preparation AG- Research design, data acquisition/research execution, manuscript preparation WR- Data acquisition/research execution AS- Research design, data acquisition/research execution DP- Research design, data acquisition/research execution QZ- Data analysis RB- Manuscript preparation JPD- Manuscript preparation JM- Manuscript preparation MLM- Manuscript preparation RBP- Manuscript preparation CLS- Manuscript preparation AGS- Manuscript preparation ZS- Manuscript preparation DW- Manuscript preparation JAH- Manuscript preparation YY- Research design, manuscript preparation.
Correspondence to Yoshihiro Yonekawa.
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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 (2022). https://doi.org/10.1038/s41433-022-02244-7
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Received: 07 March 2022
Revised: 07 July 2022
Accepted: 05 September 2022
Published: 19 September 2022
DOI: https://doi.org/10.1038/s41433-022-02244-7
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