{"id":"https://openalex.org/W4387764686","doi":"https://doi.org/10.1111/1756-185x.14944","title":"Characteristics of race/ethnicity in trials leading to anti\u2010rheumatic drug approval for inflammatory arthritis by the US Food and Drug Administration","display_name":"Characteristics of race/ethnicity in trials leading to anti\u2010rheumatic drug approval for inflammatory arthritis by the US Food and Drug Administration","publication_year":2023,"publication_date":"2023-10-18","ids":{"openalex":"https://openalex.org/W4387764686","doi":"https://doi.org/10.1111/1756-185x.14944","pmid":"https://pubmed.ncbi.nlm.nih.gov/37854006"},"language":"en","primary_location":{"id":"doi:10.1111/1756-185x.14944","doi":"https://doi.org/10.1111/1756-185x.14944","is_oa":false,"landing_page_url":"https://doi.org/10.1111/1756-185x.14944","pdf_url":null,"source":{"id":"https://openalex.org/S169069398","display_name":"International Journal of Rheumatic Diseases","issn_l":"1756-1841","issn":["1756-1841","1756-185X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-c","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-70","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Rheumatic Diseases","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5060671062","display_name":"Yan Xie","orcid":"https://orcid.org/0000-0001-8987-4844","observed_orcids":["https://orcid.org/0000-0001-8987-4844"]},"institutions":[{"id":"https://openalex.org/I24185976","display_name":"Sichuan University","ror":"https://ror.org/011ashp19","country_code":"CN","type":"education","lineage":["https://openalex.org/I24185976"]},{"id":"https://openalex.org/I4210089761","display_name":"West China Hospital of Sichuan University","ror":"https://ror.org/007mrxy13","country_code":"CN","type":"healthcare","lineage":["https://openalex.org/I4210089761"]}],"countries":["CN"],"is_corresponding":false,"raw_author_name":"Yan Xie","raw_affiliation_strings":["Department of Rheumatology and Immunology, West China Hospital, Sichuan University, Chengdu, China"],"raw_orcid":"https://orcid.org/0000-0001-8987-4844","affiliations":[{"raw_affiliation_string":"Department of Rheumatology and Immunology, West China Hospital, Sichuan University, Chengdu, China","institution_ids":["https://openalex.org/I24185976","https://openalex.org/I4210089761"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5100355638","display_name":"Yang Liu","orcid":"https://orcid.org/0000-0001-5477-2186","observed_orcids":["https://orcid.org/0000-0001-5477-2186","https://orcid.org/0009-0004-2020-2870"]},"institutions":[{"id":"https://openalex.org/I4210153550","display_name":"Beijing Tsinghua Chang Gung Hospital","ror":"https://ror.org/050nfgr37","country_code":"CN","type":"healthcare","lineage":["https://openalex.org/I4210153550"]},{"id":"https://openalex.org/I99065089","display_name":"Tsinghua University","ror":"https://ror.org/03cve4549","country_code":"CN","type":"education","lineage":["https://openalex.org/I99065089"]}],"countries":["CN"],"is_corresponding":false,"raw_author_name":"Yang Liu","raw_affiliation_strings":["Clinical Trial Institute, Beijing Tsinghua Changgung Hospital, Beijing, China","Tsinghua Clinical Research Institute (TCRI), School of Medicine, Tsinghua University, Beijing, China"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Trial Institute, Beijing Tsinghua Changgung Hospital, Beijing, China","institution_ids":["https://openalex.org/I4210153550"]},{"raw_affiliation_string":"Tsinghua Clinical Research Institute (TCRI), School of Medicine, Tsinghua University, Beijing, China","institution_ids":["https://openalex.org/I99065089"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5076745537","display_name":"Yunhe Qin","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Yunhe Qin","raw_affiliation_strings":["Pharmcube (Beijing) Co., Ltd., Beijing, China"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Pharmcube (Beijing) Co., Ltd., Beijing, China","institution_ids":[]}]},{"author_position":"middle","author":{"id":null,"display_name":"Xiaoyuan Chen","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210153550","display_name":"Beijing Tsinghua Chang Gung Hospital","ror":"https://ror.org/050nfgr37","country_code":"CN","type":"healthcare","lineage":["https://openalex.org/I4210153550"]},{"id":"https://openalex.org/I99065089","display_name":"Tsinghua University","ror":"https://ror.org/03cve4549","country_code":"CN","type":"education","lineage":["https://openalex.org/I99065089"]}],"countries":["CN"],"is_corresponding":true,"raw_author_name":"Xiaoyuan Chen","raw_affiliation_strings":["Clinical Trial Institute, Beijing Tsinghua Changgung Hospital, Beijing, China","Tsinghua Clinical Research Institute (TCRI), School of Medicine, Tsinghua University, Beijing, China"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Trial Institute, Beijing Tsinghua Changgung Hospital, Beijing, China","institution_ids":["https://openalex.org/I4210153550"]},{"raw_affiliation_string":"Tsinghua Clinical Research Institute (TCRI), School of Medicine, Tsinghua University, Beijing, China","institution_ids":["https://openalex.org/I99065089"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5034312079","display_name":"Qibing Xie","orcid":"https://orcid.org/0000-0002-6727-1839","observed_orcids":["https://orcid.org/0000-0002-6727-1839","https://orcid.org/0000-0003-0438-5975"]},"institutions":[{"id":"https://openalex.org/I24185976","display_name":"Sichuan University","ror":"https://ror.org/011ashp19","country_code":"CN","type":"education","lineage":["https://openalex.org/I24185976"]},{"id":"https://openalex.org/I4210089761","display_name":"West China Hospital of Sichuan University","ror":"https://ror.org/007mrxy13","country_code":"CN","type":"healthcare","lineage":["https://openalex.org/I4210089761"]}],"countries":["CN"],"is_corresponding":true,"raw_author_name":"Qibing Xie","raw_affiliation_strings":["Department of Rheumatology and Immunology, West China Hospital, Sichuan University, Chengdu, China"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Rheumatology and Immunology, West China Hospital, Sichuan University, Chengdu, China","institution_ids":["https://openalex.org/I24185976","https://openalex.org/I4210089761"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":4,"corresponding_author_ids":["https://openalex.org/A5034312079"],"corresponding_institution_ids":["https://openalex.org/I24185976","https://openalex.org/I4210089761","https://openalex.org/I4210153550","https://openalex.org/I99065089"],"apc_list":{"value":3350,"currency":"USD","value_usd":3350},"apc_paid":null,"fwci":0.5096,"has_fulltext":false,"cited_by_count":2,"citation_normalized_percentile":{"value":0.66193368,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":90,"max":96},"biblio":{"volume":"26","issue":"12","first_page":"2489","last_page":"2497"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10582","display_name":"Ethics in Clinical Research","score":0.8726000189781189,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10582","display_name":"Ethics in Clinical Research","score":0.8726000189781189,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T12749","display_name":"Race, Genetics, and Society","score":0.08070000261068344,"subfield":{"id":"https://openalex.org/subfields/1311","display_name":"Genetics"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.012299999594688416,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/racial-and-ethnic-disparities","display_name":"racial and ethnic disparities","score":0.8529999852180481},{"id":"https://openalex.org/keywords/clinical-trial-enrollment","display_name":"clinical trial recruitment","score":0.6880000233650208},{"id":"https://openalex.org/keywords/inflammatory-arthritis","display_name":"inflammatory arthritis","score":0.9850000143051147},{"id":"https://openalex.org/keywords/rheumatoid-arthritis","display_name":"rheumatoid arthritis","score":0.8230000138282776},{"id":"https://openalex.org/keywords/psoriatic-arthritis","display_name":"psoriatic arthritis","score":0.9990000128746033},{"id":"https://openalex.org/keywords/spondyloarthritis","display_name":"spondyloarthritis","score":0.9990000128746033},{"id":"https://openalex.org/keywords/us-food-and-drug-administration","display_name":"US Food and Drug Administration","score":0.7160000205039978}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9044915437698364},{"id":"https://openalex.org/C137403100","wikidata":"https://www.wikidata.org/wiki/Q41710","display_name":"Ethnic group","level":2,"score":0.7759703993797302},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.6888536214828491},{"id":"https://openalex.org/C3018890749","wikidata":"https://www.wikidata.org/wiki/Q204711","display_name":"Food and drug administration","level":2,"score":0.548554003238678},{"id":"https://openalex.org/C76509639","wikidata":"https://www.wikidata.org/wiki/Q918036","display_name":"Race (biology)","level":2,"score":0.5435273051261902},{"id":"https://openalex.org/C2777575956","wikidata":"https://www.wikidata.org/wiki/Q187255","display_name":"Rheumatoid arthritis","level":2,"score":0.5291956663131714},{"id":"https://openalex.org/C512399662","wikidata":"https://www.wikidata.org/wiki/Q3505712","display_name":"Family medicine","level":1,"score":0.41099774837493896},{"id":"https://openalex.org/C149923435","wikidata":"https://www.wikidata.org/wiki/Q37732","display_name":"Demography","level":1,"score":0.35520678758621216},{"id":"https://openalex.org/C74909509","wikidata":"https://www.wikidata.org/wiki/Q10387","display_name":"Gerontology","level":1,"score":0.3492034673690796},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.3082941770553589},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.16755253076553345},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.0},{"id":"https://openalex.org/C59822182","wikidata":"https://www.wikidata.org/wiki/Q441","display_name":"Botany","level":1,"score":0.0},{"id":"https://openalex.org/C144024400","wikidata":"https://www.wikidata.org/wiki/Q21201","display_name":"Sociology","level":0,"score":0.0},{"id":"https://openalex.org/C19165224","wikidata":"https://www.wikidata.org/wiki/Q23404","display_name":"Anthropology","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D001172","descriptor_name":"Arthritis, Rheumatoid","qualifier_ui":"Q000175","qualifier_name":"diagnosis","is_major_topic":true},{"descriptor_ui":"D001172","descriptor_name":"Arthritis, Rheumatoid","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D005006","descriptor_name":"Ethnicity","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D015535","descriptor_name":"Arthritis, Psoriatic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D018501","descriptor_name":"Antirheumatic Agents","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.1111/1756-185x.14944","doi":"https://doi.org/10.1111/1756-185x.14944","is_oa":false,"landing_page_url":"https://doi.org/10.1111/1756-185x.14944","pdf_url":null,"source":{"id":"https://openalex.org/S169069398","display_name":"International Journal of Rheumatic Diseases","issn_l":"1756-1841","issn":["1756-1841","1756-185X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-c","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-70","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Rheumatic Diseases","raw_type":"journal-article"},{"id":"pmid:37854006","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/37854006","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International journal of rheumatic diseases","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":0.9537000060081482},{"id":"https://metadata.un.org/sdg/10","display_name":"Reduced inequalities","score":0.7578999996185303}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":29,"referenced_works":["https://openalex.org/W1918881530","https://openalex.org/W1987716198","https://openalex.org/W2025242288","https://openalex.org/W2038878509","https://openalex.org/W2066669194","https://openalex.org/W2075765029","https://openalex.org/W2145172939","https://openalex.org/W2395797371","https://openalex.org/W2509529148","https://openalex.org/W2515764821","https://openalex.org/W2743156512","https://openalex.org/W2900081888","https://openalex.org/W2969031691","https://openalex.org/W2971109628","https://openalex.org/W2983391999","https://openalex.org/W2989004662","https://openalex.org/W3007410422","https://openalex.org/W3044817023","https://openalex.org/W3118601452","https://openalex.org/W3133828326","https://openalex.org/W3134780383","https://openalex.org/W3154295340","https://openalex.org/W3193948359","https://openalex.org/W3196308161","https://openalex.org/W3202507436","https://openalex.org/W4205317825","https://openalex.org/W4289339996","https://openalex.org/W4295885254","https://openalex.org/W4310329729"],"related_works":["https://openalex.org/W4417196508","https://openalex.org/W3199148741","https://openalex.org/W7212007123","https://openalex.org/W4225742951","https://openalex.org/W4376104438","https://openalex.org/W3154295340","https://openalex.org/W3208073291","https://openalex.org/W4410503454","https://openalex.org/W4365459067","https://openalex.org/W4283692985"],"abstract_inverted_index":{"OBJECTIVE:":[0],"Presenting":[1],"the":[2,17,26,35,50,63,73,84,101,134,140,160,204,215,228],"racial/ethnic":[3,29,202],"representation":[4],"in":[5,126,156,171,194,209],"clinical":[6,119,211],"trials":[7,33,68,152,212],"leading":[8],"to":[9,24,43,109,139,200,214],"new":[10,38,112],"approvals":[11,113],"of":[12,28,37,66,72,92,129,166,182,187],"inflammatory":[13],"arthritis":[14,173],"(IA)":[15],"by":[16,59],"US":[18,103,142,217],"Food":[19],"and":[20,62,76,97,131,147,177,184,189,227],"Drug":[21],"Administration":[22],"(FDA)":[23],"determine":[25],"extent":[27],"disparities.":[30],"METHODS:":[31],"Pivotal":[32],"supporting":[34],"approval":[36],"indications":[39],"from":[40,48],"July":[41],"2012":[42,108],"June":[44],"2022":[45],"were":[46,56,87,95,114,168,191],"collected":[47],"Drugs@FDA,":[49],"FDA-approved":[51],"drugs":[52,75],"database.":[53],"More":[54],"details":[55],"then":[57,98],"identified":[58,115],"searching":[60],"Pubmed":[61],"National":[64],"Institutes":[65],"Health":[67],"registry.":[69],"General":[70],"characteristics":[71],"approved":[74],"demographic":[77],"data":[78],"for":[79,159],"each":[80,93],"pivotal":[81,151,210],"trial,":[82],"especially":[83],"race/ethnicity":[85,94,219],"data,":[86],"collected.":[88],"The":[89,121,222],"enrollment":[90],"profiles":[91],"analyzed":[96],"compared":[99,138,213],"with":[100],"2020":[102,141,216],"census":[104,143],"data.":[105,144,221],"RESULTS:":[106],"From":[107],"2022,":[110],"34":[111],"based":[116],"on":[117],"59":[118],"trials.":[120],"Black":[122,183,205],"was":[123,136,206,224,237],"consistently":[124,207,225],"underrepresented":[125,208],"all":[127],"subtypes":[128],"IA":[130],"drugs,":[132],"while":[133,179],"White":[135,167,223],"overrepresented":[137],"For":[145],"Asian":[146,188],"Hispanic":[148,190,229],"participants,":[149],"these":[150],"presented":[153,230],"relatively":[154],"heterogeneities":[155],"enrollments.":[157],"As":[158],"trends":[161],"over":[162],"time,":[163],"increased":[164,180],"involvements":[165,181],"still":[169],"observed":[170,193],"rheumatoid":[172],"(RA),":[174],"psoriatic":[175],"arthritis,":[176],"spondyloarthritis,":[178],"decreased":[185],"enrollments":[186],"only":[192],"RA.":[195],"CONCLUSIONS:":[196],"Despite":[197],"many":[198],"efforts":[199],"eliminate":[201],"disparities,":[203],"national":[218],"distribution":[220],"overrepresented,":[226],"heterogeneous":[231],"results.":[232],"No":[233],"evident":[234],"time":[235],"trend":[236],"observed.":[238]},"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2025,"cited_by_count":1}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2023-10-20T00:00:00"}