{"id":"https://openalex.org/W2768040418","doi":"https://doi.org/10.1016/j.jclinepi.2017.11.003","title":"Trial registry searches for randomized controlled trials of new drugs required registry-specific adaptation to achieve adequate sensitivity","display_name":"Trial registry searches for randomized controlled trials of new drugs required registry-specific adaptation to achieve adequate sensitivity","publication_year":2017,"publication_date":"2017-11-11","ids":{"openalex":"https://openalex.org/W2768040418","doi":"https://doi.org/10.1016/j.jclinepi.2017.11.003","mag":"2768040418","pmid":"https://pubmed.ncbi.nlm.nih.gov/29132833"},"language":"en","primary_location":{"id":"doi:10.1016/j.jclinepi.2017.11.003","doi":"https://doi.org/10.1016/j.jclinepi.2017.11.003","is_oa":true,"landing_page_url":"https://doi.org/10.1016/j.jclinepi.2017.11.003","pdf_url":null,"source":{"id":"https://openalex.org/S64418186","display_name":"Journal of Clinical Epidemiology","issn_l":"0895-4356","issn":["0895-4356","1878-5921"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Epidemiology","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://doi.org/10.1016/j.jclinepi.2017.11.003","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5014665124","display_name":"Marco Knelangen","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I3132465597","display_name":"Institute for Quality and Efficiency in Health Care","ror":"https://ror.org/02qz3vm75","country_code":"DE","type":"facility","lineage":["https://openalex.org/I3132465597"]}],"countries":["DE"],"is_corresponding":true,"raw_author_name":"Marco Knelangen","raw_affiliation_strings":["Information Management Unit, Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670 Cologne, Germany. Electronic address: marco.knelangen@iqwig.de","Information Management Unit, Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670 Cologne, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Information Management Unit, Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670 Cologne, Germany. Electronic address: marco.knelangen@iqwig.de","institution_ids":["https://openalex.org/I3132465597"]},{"raw_affiliation_string":"Information Management Unit, Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670 Cologne, Germany","institution_ids":["https://openalex.org/I3132465597"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5032525822","display_name":"Elke Hausner","orcid":"https://orcid.org/0000-0003-2126-0904","observed_orcids":["https://orcid.org/0000-0003-2126-0904"]},"institutions":[{"id":"https://openalex.org/I3132465597","display_name":"Institute for Quality and Efficiency in Health Care","ror":"https://ror.org/02qz3vm75","country_code":"DE","type":"facility","lineage":["https://openalex.org/I3132465597"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Elke Hausner","raw_affiliation_strings":["Information Management Unit, Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670 Cologne, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Information Management Unit, Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670 Cologne, Germany","institution_ids":["https://openalex.org/I3132465597"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5066886079","display_name":"Maria\u2010Inti Metzendorf","orcid":"https://orcid.org/0000-0002-4154-5782","observed_orcids":["https://orcid.org/0000-0002-4154-5782"]},"institutions":[{"id":"https://openalex.org/I44260953","display_name":"Heinrich Heine University D\u00fcsseldorf","ror":"https://ror.org/024z2rq82","country_code":"DE","type":"education","lineage":["https://openalex.org/I44260953"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Maria-Inti Metzendorf","raw_affiliation_strings":["Cochrane Metabolic and Endocrine Disorders Group, Institute of General Practice, Medical Faculty of the Heinrich-Heine-University, Moorenstr. 5, 40225 D\u00fcsseldorf, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Cochrane Metabolic and Endocrine Disorders Group, Institute of General Practice, Medical Faculty of the Heinrich-Heine-University, Moorenstr. 5, 40225 D\u00fcsseldorf, Germany","institution_ids":["https://openalex.org/I44260953"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5007003209","display_name":"Sibylle Sturtz","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I3132465597","display_name":"Institute for Quality and Efficiency in Health Care","ror":"https://ror.org/02qz3vm75","country_code":"DE","type":"facility","lineage":["https://openalex.org/I3132465597"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Sibylle Sturtz","raw_affiliation_strings":["Department of Medical Biometry, Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670 Cologne, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medical Biometry, Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670 Cologne, Germany","institution_ids":["https://openalex.org/I3132465597"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5010579297","display_name":"Siw Waffenschmidt","orcid":"https://orcid.org/0000-0001-6860-6699","observed_orcids":["https://orcid.org/0000-0001-6860-6699"]},"institutions":[{"id":"https://openalex.org/I3132465597","display_name":"Institute for Quality and Efficiency in Health Care","ror":"https://ror.org/02qz3vm75","country_code":"DE","type":"facility","lineage":["https://openalex.org/I3132465597"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Siw Waffenschmidt","raw_affiliation_strings":["Information Management Unit, Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670 Cologne, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Information Management Unit, Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670 Cologne, Germany","institution_ids":["https://openalex.org/I3132465597"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":["https://openalex.org/A5014665124"],"corresponding_institution_ids":["https://openalex.org/I3132465597"],"apc_list":{"value":4210,"currency":"USD","value_usd":4210},"apc_paid":{"value":4210,"currency":"USD","value_usd":4210},"fwci":1.9562,"has_fulltext":false,"cited_by_count":15,"citation_normalized_percentile":{"value":0.86896599,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":98},"biblio":{"volume":"94","issue":null,"first_page":"69","last_page":"75"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10206","display_name":"Meta-analysis and systematic reviews","score":0.8705999851226807,"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":0.8705999851226807,"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/T11649","display_name":"Pharmaceutical industry and healthcare","score":0.0812000036239624,"subfield":{"id":"https://openalex.org/subfields/3004","display_name":"Pharmacology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.009499999694526196,"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/randomized-controlled-trials","display_name":"randomized controlled trials","score":0.718999981880188},{"id":"https://openalex.org/keywords/newly-approved-drugs","display_name":"newly approved drugs","score":0.9240000247955322},{"id":"https://openalex.org/keywords/clinicaltrials-gov","display_name":"ClinicalTrials.gov","score":0.8510000109672546},{"id":"https://openalex.org/keywords/international-clinical-trials-registry-platform","display_name":"International Clinical Trials Registry Platform","score":0.9900000095367432},{"id":"https://openalex.org/keywords/search-sensitivity","display_name":"search sensitivity","score":0.8109999895095825}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7840468883514404},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.6873730421066284},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.6338125467300415},{"id":"https://openalex.org/C2778653282","wikidata":"https://www.wikidata.org/wiki/Q60752967","display_name":"Trial registration","level":3,"score":0.44028007984161377},{"id":"https://openalex.org/C19527891","wikidata":"https://www.wikidata.org/wiki/Q1120908","display_name":"Medical physics","level":1,"score":0.3217613101005554},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.27420732378959656}],"mesh":[{"descriptor_ui":"D004358","descriptor_name":"Drug Therapy","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005060","descriptor_name":"Europe","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":"D012042","descriptor_name":"Registries","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012680","descriptor_name":"Sensitivity and Specificity","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":"D016032","descriptor_name":"Randomized Controlled Trials as Topic","qualifier_ui":"Q000706","qualifier_name":"statistics & numerical data","is_major_topic":true},{"descriptor_ui":"D057386","descriptor_name":"Search Engine","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.1016/j.jclinepi.2017.11.003","doi":"https://doi.org/10.1016/j.jclinepi.2017.11.003","is_oa":true,"landing_page_url":"https://doi.org/10.1016/j.jclinepi.2017.11.003","pdf_url":null,"source":{"id":"https://openalex.org/S64418186","display_name":"Journal of Clinical Epidemiology","issn_l":"0895-4356","issn":["0895-4356","1878-5921"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Epidemiology","raw_type":"journal-article"},{"id":"pmid:29132833","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/29132833","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":"Journal of clinical epidemiology","raw_type":"Journal Article"}],"best_oa_location":{"id":"doi:10.1016/j.jclinepi.2017.11.003","doi":"https://doi.org/10.1016/j.jclinepi.2017.11.003","is_oa":true,"landing_page_url":"https://doi.org/10.1016/j.jclinepi.2017.11.003","pdf_url":null,"source":{"id":"https://openalex.org/S64418186","display_name":"Journal of Clinical Epidemiology","issn_l":"0895-4356","issn":["0895-4356","1878-5921"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":"cc-by-nc-nd","license_id":"https://openalex.org/licenses/cc-by-nc-nd","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Clinical Epidemiology","raw_type":"journal-article"},"sustainable_development_goals":[{"score":0.8999999761581421,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"sustainable_development_goals_aurora":[],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":17,"referenced_works":["https://openalex.org/W118549185","https://openalex.org/W1492667025","https://openalex.org/W1546847154","https://openalex.org/W1802708045","https://openalex.org/W1970350518","https://openalex.org/W2020248812","https://openalex.org/W2022226672","https://openalex.org/W2066059360","https://openalex.org/W2069222729","https://openalex.org/W2120902818","https://openalex.org/W2130035612","https://openalex.org/W2131495796","https://openalex.org/W2149557260","https://openalex.org/W2250548332","https://openalex.org/W2269763616","https://openalex.org/W2588165446","https://openalex.org/W4362504902"],"related_works":["https://openalex.org/W2784304549","https://openalex.org/W4392138024","https://openalex.org/W1979047500","https://openalex.org/W4386859869","https://openalex.org/W2995493303","https://openalex.org/W1990616922","https://openalex.org/W1494265273","https://openalex.org/W7095280157","https://openalex.org/W2903473779","https://openalex.org/W2134048257"],"abstract_inverted_index":{"OBJECTIVES:":[0],"To":[1],"analyze":[2],"the":[3,27,34,55,58,93,113,135,139,143],"availability":[4],"of":[5,10,57,79,82,120,138,161],"randomized":[6],"controlled":[7],"trials":[8,96],"(RCTs)":[9],"new":[11,110],"drugs":[12,88,111,173],"in":[13,24,61,91,122,142,163,178,184,195],"trial":[14],"registries":[15],"and":[16,19,33,64,71,197],"to":[17,73],"develop":[18],"test":[20],"different":[21,66],"search":[22,67,156,183,191,202],"strategies":[23,68],"ClinicalTrials.gov":[25],"(CT.gov),":[26],"EU":[28],"Clinical":[29,36],"Trials":[30,37],"Register":[31],"(EU-CTR),":[32],"International":[35],"Registry":[38],"Platform":[39],"(ICTRP).":[40],"STUDY":[41],"DESIGN":[42],"AND":[43],"SETTING:":[44],"Information":[45],"from":[46],"dossiers":[47],"submitted":[48],"by":[49],"pharmaceutical":[50],"companies":[51],"was":[52,134],"analyzed":[53],"regarding":[54],"registration":[56],"included":[59],"RCTs":[60,84,107,149,169],"CT.gov,":[62],"EU-CTR":[63,198],"ICTRP;":[65],"were":[69,89,97],"developed":[70],"tested":[72],"determine":[74],"performance.":[75],"RESULTS:":[76],"A":[77,181],"total":[78],"192":[80],"(95%)":[81],"203":[83],"on":[85,108,150,170],"newly":[86,171],"approved":[87,172],"registered":[90],"CT.gov;":[92],"11":[94],"nonregistered":[95],"completed":[98],"before":[99],"2005":[100],"or":[101],"represented":[102],"non-RCTs.":[103],"Simple":[104,146],"searches":[105,147,194],"for":[106,131,148],"18":[109],"using":[112,153,189],"generic":[114],"drug":[115,140],"name":[116],"yielded":[117,158],"a":[118,159],"sensitivity":[119,160],"94%":[121],"CT.gov":[123,179,185],"(EU-CTR:":[124],"71%;":[125],"ICTRP:":[126],"60%).":[127],"The":[128,193],"main":[129],"reason":[130],"study":[132],"nondetection":[133],"sole":[136],"use":[137],"code":[141],"registry":[144],"entries.":[145],"13":[151],"conditions":[152],"reasonably":[154],"inferred":[155],"terms":[157,203],"100%":[162],"CT.gov.":[164],"CONCLUSION:":[165],"Almost":[166],"all":[167],"relevant":[168],"will":[174],"probably":[175],"be":[176,187],"identified":[177],"alone.":[180],"sensitive":[182],"can":[186],"conducted":[188],"single":[190],"terms.":[192],"ICTRP":[196],"should":[199],"include":[200],"several":[201],"(e.g.,":[204],"derived":[205],"via":[206],"text":[207],"analysis).":[208]},"counts_by_year":[{"year":2024,"cited_by_count":3},{"year":2023,"cited_by_count":2},{"year":2022,"cited_by_count":1},{"year":2021,"cited_by_count":1},{"year":2020,"cited_by_count":4},{"year":2019,"cited_by_count":4}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2017-11-17T00:00:00"}