{"id":"https://openalex.org/W2946406979","doi":"https://doi.org/10.1093/jamia/ocz047","title":"New requirements for clinical trial transparency provide new opportunities for informatics research","display_name":"New requirements for clinical trial transparency provide new opportunities for informatics research","publication_year":2019,"publication_date":"2019-04-04","ids":{"openalex":"https://openalex.org/W2946406979","doi":"https://doi.org/10.1093/jamia/ocz047","mag":"2946406979","pmid":"https://pubmed.ncbi.nlm.nih.gov/31087069"},"language":"en","primary_location":{"id":"doi:10.1093/jamia/ocz047","is_oa":false,"landing_page_url":"https://doi.org/10.1093/jamia/ocz047","pdf_url":null,"source":{"id":"https://openalex.org/S129839026","display_name":"Journal of the American Medical Informatics Association","issn_l":"1067-5027","issn":["1067-5027","1527-974X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of the American Medical Informatics Association","raw_type":"journal-article"},"type":"editorial","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/7647345","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5109011956","display_name":"Betsy L. Humphreys","orcid":null},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"Betsy L Humphreys","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":["https://openalex.org/A5109011956"],"corresponding_institution_ids":[],"apc_list":{"value":3967,"currency":"USD","value_usd":3967},"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":4,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"26","issue":"6","first_page":"493","last_page":"494"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10206","display_name":"Meta-analysis and systematic reviews","score":0.9973999857902527,"subfield":{"id":"https://openalex.org/subfields/1804","display_name":"Statistics, Probability and Uncertainty"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T10206","display_name":"Meta-analysis and systematic reviews","score":0.9973999857902527,"subfield":{"id":"https://openalex.org/subfields/1804","display_name":"Statistics, Probability and Uncertainty"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T10582","display_name":"Ethics in Clinical Research","score":0.9968000054359436,"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/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.9889000058174133,"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/clinical-trial","display_name":"Clinical trial","score":0.780666708946228},{"id":"https://openalex.org/keywords/credibility","display_name":"Credibility","score":0.6960009336471558},{"id":"https://openalex.org/keywords/transparency","display_name":"Transparency (behavior)","score":0.6881263256072998},{"id":"https://openalex.org/keywords/protocol","display_name":"Protocol (science)","score":0.6816443800926208},{"id":"https://openalex.org/keywords/consolidated-standards-of-reporting-trials","display_name":"Consolidated Standards of Reporting Trials","score":0.5407093167304993},{"id":"https://openalex.org/keywords/food-and-drug-administration","display_name":"Food and drug administration","score":0.5038227438926697},{"id":"https://openalex.org/keywords/informatics","display_name":"Informatics","score":0.4722532629966736},{"id":"https://openalex.org/keywords/medicine","display_name":"Medicine","score":0.46593230962753296},{"id":"https://openalex.org/keywords/clinical-research","display_name":"Clinical research","score":0.4206509590148926},{"id":"https://openalex.org/keywords/medical-physics","display_name":"Medical physics","score":0.39432987570762634},{"id":"https://openalex.org/keywords/alternative-medicine","display_name":"Alternative medicine","score":0.39027294516563416},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.33730649948120117},{"id":"https://openalex.org/keywords/risk-analysis","display_name":"Risk analysis (engineering)","score":0.2151051163673401},{"id":"https://openalex.org/keywords/political-science","display_name":"Political science","score":0.1364172399044037},{"id":"https://openalex.org/keywords/pathology","display_name":"Pathology","score":0.1122475266456604},{"id":"https://openalex.org/keywords/computer-security","display_name":"Computer security","score":0.08882680535316467}],"concepts":[{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.780666708946228},{"id":"https://openalex.org/C2780224610","wikidata":"https://www.wikidata.org/wiki/Q1530061","display_name":"Credibility","level":2,"score":0.6960009336471558},{"id":"https://openalex.org/C2780233690","wikidata":"https://www.wikidata.org/wiki/Q535347","display_name":"Transparency (behavior)","level":2,"score":0.6881263256072998},{"id":"https://openalex.org/C2780385302","wikidata":"https://www.wikidata.org/wiki/Q367158","display_name":"Protocol (science)","level":3,"score":0.6816443800926208},{"id":"https://openalex.org/C49290038","wikidata":"https://www.wikidata.org/wiki/Q2994654","display_name":"Consolidated Standards of Reporting Trials","level":3,"score":0.5407093167304993},{"id":"https://openalex.org/C3018890749","wikidata":"https://www.wikidata.org/wiki/Q204711","display_name":"Food and drug administration","level":2,"score":0.5038227438926697},{"id":"https://openalex.org/C191630685","wikidata":"https://www.wikidata.org/wiki/Q4027615","display_name":"Informatics","level":2,"score":0.4722532629966736},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.46593230962753296},{"id":"https://openalex.org/C502991105","wikidata":"https://www.wikidata.org/wiki/Q5133849","display_name":"Clinical research","level":2,"score":0.4206509590148926},{"id":"https://openalex.org/C19527891","wikidata":"https://www.wikidata.org/wiki/Q1120908","display_name":"Medical physics","level":1,"score":0.39432987570762634},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.39027294516563416},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.33730649948120117},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.2151051163673401},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.1364172399044037},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.1122475266456604},{"id":"https://openalex.org/C38652104","wikidata":"https://www.wikidata.org/wiki/Q3510521","display_name":"Computer security","level":1,"score":0.08882680535316467},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D008490","descriptor_name":"Medical Informatics","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D008490","descriptor_name":"Medical Informatics","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D008490","descriptor_name":"Medical Informatics","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D016208","descriptor_name":"Databases, Factual","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D016208","descriptor_name":"Databases, Factual","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D016208","descriptor_name":"Databases, Factual","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D017408","descriptor_name":"Guidelines as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D017408","descriptor_name":"Guidelines as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D017408","descriptor_name":"Guidelines as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D035843","descriptor_name":"Biomedical Research","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D035843","descriptor_name":"Biomedical Research","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D035843","descriptor_name":"Biomedical Research","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false}],"locations_count":3,"locations":[{"id":"doi:10.1093/jamia/ocz047","is_oa":false,"landing_page_url":"https://doi.org/10.1093/jamia/ocz047","pdf_url":null,"source":{"id":"https://openalex.org/S129839026","display_name":"Journal of the American Medical Informatics Association","issn_l":"1067-5027","issn":["1067-5027","1527-974X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of the American Medical Informatics Association","raw_type":"journal-article"},{"id":"pmid:31087069","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/31087069","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,"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":"Journal of the American Medical Informatics Association : JAMIA","raw_type":null},{"id":"pmh:oai:pubmedcentral.nih.gov:7647345","is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/7647345","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"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":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"J Am Med Inform Assoc","raw_type":"Text"}],"best_oa_location":{"id":"pmh:oai:pubmedcentral.nih.gov:7647345","is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/7647345","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"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":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"J Am Med Inform Assoc","raw_type":"Text"},"sustainable_development_goals":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":12,"referenced_works":["https://openalex.org/W1788491752","https://openalex.org/W2008023699","https://openalex.org/W2108696783","https://openalex.org/W2166023752","https://openalex.org/W2782908833","https://openalex.org/W2804165413","https://openalex.org/W2913154181","https://openalex.org/W2921584209","https://openalex.org/W2940314765","https://openalex.org/W4292763654","https://openalex.org/W4292807770","https://openalex.org/W6761582856"],"related_works":["https://openalex.org/W2388687352","https://openalex.org/W2370187191","https://openalex.org/W1990162851","https://openalex.org/W2369854048","https://openalex.org/W2374291020","https://openalex.org/W2355907197","https://openalex.org/W2031433373","https://openalex.org/W2002669314","https://openalex.org/W4300649974","https://openalex.org/W2301944771"],"abstract_inverted_index":{"This":[0],"editorial":[1],"continues":[2],"a":[3],"series":[4],"focused":[5],"on":[6],"improving":[7],"the":[8,20,28,58,76,103,119,131,134,141,150,159,164,180],"credibility,":[9],"transparency,":[10],"reproducibility,":[11],"and":[12,23,31,39,45,65,74,78,82,105,123,196],"replicability":[13],"of":[14,33,41,90,102,111,118,136,143,154,183,187,200],"biomedical":[15],"informatics":[16],"research.1,2":[17],"It":[18,50],"addresses":[19],"new":[21],"responsibilities":[22],"opportunities":[24],"that":[25,55,158],"arise":[26],"from":[27],"recent":[29],"clarification":[30],"expansion":[32],"requirements":[34,77,115,162],"for":[35,61,80,86],"clinical":[36,88,171],"trials":[37,89,172,199],"registration":[38],"deposit":[40,117],"summary":[42,84],"results":[43,85,137],"data":[44],"trial":[46],"documents":[47],"in":[48,56,97,130,148,163,174,177],"ClinicalTrials.gov.":[49],"should":[51],"not":[52,128],"be":[53],"news":[54],"2016":[57],"Final":[59,165],"Rule":[60,166],"Clinical":[62],"Trials":[63],"Registration":[64],"Results":[66],"Information":[67],"Submission":[68],"(42":[69],"CFR":[70],"Part":[71],"11)3":[72],"clarified":[73],"expanded":[75,114],"procedures":[79],"registering":[81],"submitting":[83],"certain":[87],"drugs,":[91],"biologics,":[92],"or":[93,176,189],"devices":[94],"to":[95,169,194],"ClinicalTrials.gov,":[96],"accordance":[98],"with":[99],"Section":[100],"801":[101],"Food":[104],"Drug":[106],"Administration":[107],"FDA":[108],"Amendments":[109],"Act":[110],"2007.":[112],"The":[113],"include":[116],"full":[120,175],"protocol":[121],"document":[122],"statistical":[124],"analysis":[125],"plan":[126],"(if":[127],"included":[129],"protocol)":[132],"at":[133],"time":[135],"submission.":[138],"Submitters":[139],"have":[140],"option":[142],"depositing":[144],"them":[145],"sooner.":[146],"Simultaneously":[147],"2016,":[149],"U.S.":[151],"National":[152],"Institutes":[153],"Health":[155],"(NIH)":[156],"stated":[157],"ClinicalTrials.gov":[160],"submission":[161],"would":[167],"apply":[168],"all":[170],"funded":[173],"part":[178],"by":[179],"NIH,":[181],"regardless":[182],"study":[184],"phase,":[185],"type":[186],"intervention,":[188],"whether":[190],"they":[191],"are":[192],"subject":[193],"laws":[195],"regulations":[197],"governing":[198],"FDA-regulated":[201],"products.4":[202]},"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2025,"cited_by_count":1},{"year":2022,"cited_by_count":1},{"year":2019,"cited_by_count":1}],"updated_date":"2026-07-29T09:40:50.615796","created_date":"2025-10-10T00:00:00"}
