Geographic and socioeconomic access disparities to Phase 3 clinical trials in ophthalmology in the United States

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. D...

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Veröffentlicht in:Eye (London) 2023-06, Vol.37 (9), p.1822-1828
Hauptverfasser: Soares, Rebecca Russ, Huang, Charles, Sharpe, James, Cobbs, Lucy, Gopal, Anand, Rao, Winnie, Samuelson, Annika, Parikh, Devayu, Zhang, Qiang, Bailey, Robert, Dunn, James P., Minor, Jade, Moster, Mark L., Penne, Robert B., Shields, Carol, Shukla, Aakriti G., Syed, Zeba, Wisner, Douglas, Haller, Julia A., Yonekawa, Yoshihiro
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container_end_page 1828
container_issue 9
container_start_page 1822
container_title Eye (London)
container_volume 37
creator Soares, Rebecca Russ
Huang, Charles
Sharpe, James
Cobbs, Lucy
Gopal, Anand
Rao, Winnie
Samuelson, Annika
Parikh, Devayu
Zhang, Qiang
Bailey, Robert
Dunn, James P.
Minor, Jade
Moster, Mark L.
Penne, Robert B.
Shields, Carol
Shukla, Aakriti G.
Syed, Zeba
Wisner, Douglas
Haller, Julia A.
Yonekawa, Yoshihiro
description 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  
doi_str_mv 10.1038/s41433-022-02244-7
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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 (&gt;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 &gt;60 min was associated with rural tracts [adjusted odds ratio (aOR) 7.60; 95% CI (5.66–10.20), p  &lt; 0.0001]; Midwest [aOR 1.84(1.15–2.96), p  = 0.01], South [aOR 2.57 (1.38–4.79), p  &lt; 0.01], and West [aOR 2.52 (1.52–4.17), p  &lt; 0.001] v. Northeast; and tracts with higher visual impairment [aOR 1.07 (1.03–1.10), p  &lt; 0.001)]; higher poverty levels [4th v.1st Quartile of population below poverty, aOR 2.26 (1.72–2.98), p  &lt; 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.</description><identifier>ISSN: 0950-222X</identifier><identifier>EISSN: 1476-5454</identifier><identifier>DOI: 10.1038/s41433-022-02244-7</identifier><identifier>PMID: 36123561</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>692/700/478/174 ; 706/703/559 ; Census ; Censuses ; Clinical trials ; Clinical Trials, Phase III as Topic ; Cross-Sectional Studies ; Humans ; Laboratory Medicine ; Medicine ; Medicine &amp; Public Health ; Ophthalmology ; Pharmaceutical Sciences/Technology ; Residence Characteristics ; Socioeconomic Disparities in Health ; Socioeconomic Factors ; Surgery ; Surgical Oncology ; United States ; Vision Disorders ; Visual impairment</subject><ispartof>Eye (London), 2023-06, Vol.37 (9), p.1822-1828</ispartof><rights>The Author(s), under exclusive licence to The Royal College of Ophthalmologists 2022. Springer Nature or its licensor holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2022. The Author(s), under exclusive licence to The Royal College of Ophthalmologists.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-900f0d1b5faea18a3ed7fb29f61157e006ee9bd29580d0cb66ed553e4a944bb23</citedby><cites>FETCH-LOGICAL-c375t-900f0d1b5faea18a3ed7fb29f61157e006ee9bd29580d0cb66ed553e4a944bb23</cites><orcidid>0000-0002-3288-3632 ; 0000-0003-1697-1496</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1038/s41433-022-02244-7$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1038/s41433-022-02244-7$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36123561$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Soares, Rebecca Russ</creatorcontrib><creatorcontrib>Huang, Charles</creatorcontrib><creatorcontrib>Sharpe, James</creatorcontrib><creatorcontrib>Cobbs, Lucy</creatorcontrib><creatorcontrib>Gopal, Anand</creatorcontrib><creatorcontrib>Rao, Winnie</creatorcontrib><creatorcontrib>Samuelson, Annika</creatorcontrib><creatorcontrib>Parikh, Devayu</creatorcontrib><creatorcontrib>Zhang, Qiang</creatorcontrib><creatorcontrib>Bailey, Robert</creatorcontrib><creatorcontrib>Dunn, James P.</creatorcontrib><creatorcontrib>Minor, Jade</creatorcontrib><creatorcontrib>Moster, Mark L.</creatorcontrib><creatorcontrib>Penne, Robert B.</creatorcontrib><creatorcontrib>Shields, Carol</creatorcontrib><creatorcontrib>Shukla, Aakriti G.</creatorcontrib><creatorcontrib>Syed, Zeba</creatorcontrib><creatorcontrib>Wisner, Douglas</creatorcontrib><creatorcontrib>Haller, Julia A.</creatorcontrib><creatorcontrib>Yonekawa, Yoshihiro</creatorcontrib><title>Geographic and socioeconomic access disparities to Phase 3 clinical trials in ophthalmology in the United States</title><title>Eye (London)</title><addtitle>Eye</addtitle><addtitle>Eye (Lond)</addtitle><description>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 (&gt;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 &gt;60 min was associated with rural tracts [adjusted odds ratio (aOR) 7.60; 95% CI (5.66–10.20), p  &lt; 0.0001]; Midwest [aOR 1.84(1.15–2.96), p  = 0.01], South [aOR 2.57 (1.38–4.79), p  &lt; 0.01], and West [aOR 2.52 (1.52–4.17), p  &lt; 0.001] v. Northeast; and tracts with higher visual impairment [aOR 1.07 (1.03–1.10), p  &lt; 0.001)]; higher poverty levels [4th v.1st Quartile of population below poverty, aOR 2.26 (1.72–2.98), p  &lt; 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.</description><subject>692/700/478/174</subject><subject>706/703/559</subject><subject>Census</subject><subject>Censuses</subject><subject>Clinical trials</subject><subject>Clinical Trials, Phase III as Topic</subject><subject>Cross-Sectional Studies</subject><subject>Humans</subject><subject>Laboratory Medicine</subject><subject>Medicine</subject><subject>Medicine &amp; Public Health</subject><subject>Ophthalmology</subject><subject>Pharmaceutical Sciences/Technology</subject><subject>Residence Characteristics</subject><subject>Socioeconomic Disparities in Health</subject><subject>Socioeconomic Factors</subject><subject>Surgery</subject><subject>Surgical Oncology</subject><subject>United States</subject><subject>Vision Disorders</subject><subject>Visual impairment</subject><issn>0950-222X</issn><issn>1476-5454</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp9kc9rFTEQx4Mo9rX6D3iQgBcvq5Nfm92jlFoLBQUteAvZZPZtyu5mTfIO_e_N81UFDx6GgZnPfBP4EPKKwTsGonufJZNCNMD5saRs9BOyY1K3jZJKPiU76BU0nPPvZ-Q853uAutTwnJyJlnGhWrYj2zXGfbLbFBy1q6c5uhDRxTUux4lzmDP1IW82hRIw0xLpl8lmpIK6OazB2ZmWFOycaVhp3KYy2XmJc9w_HAdlQnq3hoKefi22YH5Bno0VxpeP_YLcfbz6dvmpuf18fXP54bZxQqvS9AAjeDao0aJlnRXo9TjwfmwZUxoBWsR-8LxXHXhwQ9uiV0qgtL2Uw8DFBXl7yt1S_HHAXMwSssN5tivGQzZcsxa6ToCs6Jt_0Pt4SGv9neEd1wBKC6gUP1EuxZwTjmZLYbHpwTAwRx_m5MNUF-aXD6Pr0evH6MOwoP9z8ltABcQJyHW17jH9ffs_sT8BAqeWhw</recordid><startdate>20230601</startdate><enddate>20230601</enddate><creator>Soares, Rebecca Russ</creator><creator>Huang, Charles</creator><creator>Sharpe, James</creator><creator>Cobbs, Lucy</creator><creator>Gopal, Anand</creator><creator>Rao, Winnie</creator><creator>Samuelson, Annika</creator><creator>Parikh, Devayu</creator><creator>Zhang, Qiang</creator><creator>Bailey, Robert</creator><creator>Dunn, James P.</creator><creator>Minor, Jade</creator><creator>Moster, Mark L.</creator><creator>Penne, Robert B.</creator><creator>Shields, Carol</creator><creator>Shukla, Aakriti G.</creator><creator>Syed, Zeba</creator><creator>Wisner, Douglas</creator><creator>Haller, Julia A.</creator><creator>Yonekawa, Yoshihiro</creator><general>Nature Publishing Group UK</general><general>Nature Publishing Group</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-3288-3632</orcidid><orcidid>https://orcid.org/0000-0003-1697-1496</orcidid></search><sort><creationdate>20230601</creationdate><title>Geographic and socioeconomic access disparities to Phase 3 clinical trials in ophthalmology in the United States</title><author>Soares, Rebecca Russ ; Huang, Charles ; Sharpe, James ; Cobbs, Lucy ; Gopal, Anand ; Rao, Winnie ; Samuelson, Annika ; Parikh, Devayu ; Zhang, Qiang ; Bailey, Robert ; Dunn, James P. ; Minor, Jade ; Moster, Mark L. ; Penne, Robert B. ; Shields, Carol ; Shukla, Aakriti G. ; Syed, Zeba ; Wisner, Douglas ; Haller, Julia A. ; Yonekawa, Yoshihiro</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-900f0d1b5faea18a3ed7fb29f61157e006ee9bd29580d0cb66ed553e4a944bb23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>692/700/478/174</topic><topic>706/703/559</topic><topic>Census</topic><topic>Censuses</topic><topic>Clinical trials</topic><topic>Clinical Trials, Phase III as Topic</topic><topic>Cross-Sectional Studies</topic><topic>Humans</topic><topic>Laboratory Medicine</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Ophthalmology</topic><topic>Pharmaceutical Sciences/Technology</topic><topic>Residence Characteristics</topic><topic>Socioeconomic Disparities in Health</topic><topic>Socioeconomic Factors</topic><topic>Surgery</topic><topic>Surgical Oncology</topic><topic>United States</topic><topic>Vision Disorders</topic><topic>Visual impairment</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Soares, Rebecca Russ</creatorcontrib><creatorcontrib>Huang, Charles</creatorcontrib><creatorcontrib>Sharpe, James</creatorcontrib><creatorcontrib>Cobbs, Lucy</creatorcontrib><creatorcontrib>Gopal, Anand</creatorcontrib><creatorcontrib>Rao, Winnie</creatorcontrib><creatorcontrib>Samuelson, Annika</creatorcontrib><creatorcontrib>Parikh, Devayu</creatorcontrib><creatorcontrib>Zhang, Qiang</creatorcontrib><creatorcontrib>Bailey, Robert</creatorcontrib><creatorcontrib>Dunn, James P.</creatorcontrib><creatorcontrib>Minor, Jade</creatorcontrib><creatorcontrib>Moster, Mark L.</creatorcontrib><creatorcontrib>Penne, Robert B.</creatorcontrib><creatorcontrib>Shields, Carol</creatorcontrib><creatorcontrib>Shukla, Aakriti G.</creatorcontrib><creatorcontrib>Syed, Zeba</creatorcontrib><creatorcontrib>Wisner, Douglas</creatorcontrib><creatorcontrib>Haller, Julia A.</creatorcontrib><creatorcontrib>Yonekawa, Yoshihiro</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Neurosciences Abstracts</collection><collection>Health &amp; 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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 (&gt;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 &gt;60 min was associated with rural tracts [adjusted odds ratio (aOR) 7.60; 95% CI (5.66–10.20), p  &lt; 0.0001]; Midwest [aOR 1.84(1.15–2.96), p  = 0.01], South [aOR 2.57 (1.38–4.79), p  &lt; 0.01], and West [aOR 2.52 (1.52–4.17), p  &lt; 0.001] v. Northeast; and tracts with higher visual impairment [aOR 1.07 (1.03–1.10), p  &lt; 0.001)]; higher poverty levels [4th v.1st Quartile of population below poverty, aOR 2.26 (1.72–2.98), p  &lt; 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.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>36123561</pmid><doi>10.1038/s41433-022-02244-7</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-3288-3632</orcidid><orcidid>https://orcid.org/0000-0003-1697-1496</orcidid><oa>free_for_read</oa></addata></record>
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1476-5454
language eng
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source MEDLINE; PubMed Central; SpringerLink Journals - AutoHoldings
subjects 692/700/478/174
706/703/559
Census
Censuses
Clinical trials
Clinical Trials, Phase III as Topic
Cross-Sectional Studies
Humans
Laboratory Medicine
Medicine
Medicine & Public Health
Ophthalmology
Pharmaceutical Sciences/Technology
Residence Characteristics
Socioeconomic Disparities in Health
Socioeconomic Factors
Surgery
Surgical Oncology
United States
Vision Disorders
Visual impairment
title Geographic and socioeconomic access disparities to Phase 3 clinical trials in ophthalmology in the United States
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