{"id":"https://openalex.org/W1819090348","doi":"https://doi.org/10.1111/j.1742-1241.2010.02481.x","title":"Cutting through the statistical fog: understanding and evaluating non-inferiority trials","display_name":"Cutting through the statistical fog: understanding and evaluating non-inferiority trials","publication_year":2010,"publication_date":"2010-08-16","ids":{"openalex":"https://openalex.org/W1819090348","doi":"https://doi.org/10.1111/j.1742-1241.2010.02481.x","mag":"1819090348","pmid":"https://pubmed.ncbi.nlm.nih.gov/20716144"},"language":"en","primary_location":{"id":"doi:10.1111/j.1742-1241.2010.02481.x","doi":"https://doi.org/10.1111/j.1742-1241.2010.02481.x","is_oa":true,"landing_page_url":"https://doi.org/10.1111/j.1742-1241.2010.02481.x","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/j.1742-1241.2010.02481.x","source":{"id":"https://openalex.org/S22344484","display_name":"International Journal of Clinical Practice","issn_l":"1368-5031","issn":["1368-5031","1742-1241"],"is_oa":false,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-scientific","cwts-core","doaj","dongbi-c","doyens","jufo-1","ki-jl-1","norway-1","poland-70","russia-white-list-1","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 Clinical Practice","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","doaj","pubmed"],"open_access":{"is_oa":true,"oa_status":"bronze","oa_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/j.1742-1241.2010.02481.x","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5052993534","display_name":"William S. Weintraub","orcid":"https://orcid.org/0000-0002-5384-5571","observed_orcids":["https://orcid.org/0000-0002-5384-5571"]},"institutions":[{"id":"https://openalex.org/I1281704429","display_name":"Christiana Care Health System","ror":"https://ror.org/02h905004","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1281704429"]},{"id":"https://openalex.org/I149251103","display_name":"Thomas Jefferson University","ror":"https://ror.org/00ysqcn41","country_code":"US","type":"education","lineage":["https://openalex.org/I149251103"]},{"id":"https://openalex.org/I4210105554","display_name":"Christiana Hospital","ror":"https://ror.org/01gxs7p86","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1281704429","https://openalex.org/I4210105554"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"W. S. Weintraub","raw_affiliation_strings":["John H. Ammon Chair, Thomas Jefferson University, Philadelphia, PA, USA. wweintraub@christianacare.org","Christiana Care Health System, Newark, DE, USA","John H. Ammon Chair, Thomas Jefferson University, Philadelphia, PA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"John H. Ammon Chair, Thomas Jefferson University, Philadelphia, PA, USA. wweintraub@christianacare.org","institution_ids":["https://openalex.org/I149251103"]},{"raw_affiliation_string":"Christiana Care Health System, Newark, DE, USA","institution_ids":["https://openalex.org/I1281704429","https://openalex.org/I4210105554"]},{"raw_affiliation_string":"John H. Ammon Chair, Thomas Jefferson University, Philadelphia, PA","institution_ids":["https://openalex.org/I149251103"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":3,"corresponding_author_ids":["https://openalex.org/A5052993534"],"corresponding_institution_ids":["https://openalex.org/I1281704429","https://openalex.org/I149251103","https://openalex.org/I4210105554"],"apc_list":{"value":2350,"currency":"USD","value_usd":2350},"apc_paid":null,"fwci":0.2727,"has_fulltext":true,"cited_by_count":4,"citation_normalized_percentile":{"value":0.62791219,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":89,"max":96},"biblio":{"volume":"64","issue":"10","first_page":"1359","last_page":"1366"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.9994999766349792,"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"}},"topics":[{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.9994999766349792,"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"}},{"id":"https://openalex.org/T10206","display_name":"Meta-analysis and systematic reviews","score":9.999999747378752e-05,"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/T10065","display_name":"Atrial Fibrillation Management and Outcomes","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2705","display_name":"Cardiology and Cardiovascular Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/equivalence-trials","display_name":"equivalence trials","score":0.9860000014305115},{"id":"https://openalex.org/keywords/trial-design-flaws","display_name":"trial design flaws","score":0.6859999895095825},{"id":"https://openalex.org/keywords/statistical-validity","display_name":"statistical validity","score":0.609000027179718},{"id":"https://openalex.org/keywords/ximelagatran","display_name":"ximelagatran","score":0.859000027179718},{"id":"https://openalex.org/keywords/warfarin","display_name":"warfarin","score":0.9810000061988831},{"id":"https://openalex.org/keywords/non-valvular-atrial-fibrillation","display_name":"non-valvular atrial fibrillation","score":0.8930000066757202},{"id":"https://openalex.org/keywords/stroke-prevention","display_name":"stroke prevention","score":0.6620000004768372},{"id":"https://openalex.org/keywords/thromboembolism","display_name":"thromboembolism","score":0.777999997138977},{"id":"https://openalex.org/keywords/sample-size","display_name":"sample size","score":0.3330000042915344},{"id":"https://openalex.org/keywords/non-inferiority-margin","display_name":"non-inferiority margin","score":0.878000020980835},{"id":"https://openalex.org/keywords/hepatotoxicity","display_name":"hepatotoxicity","score":0.36500000953674316}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9219672679901123},{"id":"https://openalex.org/C2776301958","wikidata":"https://www.wikidata.org/wiki/Q407431","display_name":"Warfarin","level":3,"score":0.6922558546066284},{"id":"https://openalex.org/C2779630707","wikidata":"https://www.wikidata.org/wiki/Q3570984","display_name":"Ximelagatran","level":5,"score":0.5964120030403137},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.5514609813690186},{"id":"https://openalex.org/C2779161974","wikidata":"https://www.wikidata.org/wiki/Q815819","display_name":"Atrial fibrillation","level":2,"score":0.5341951251029968},{"id":"https://openalex.org/C2780645631","wikidata":"https://www.wikidata.org/wiki/Q671554","display_name":"Stroke (engine)","level":2,"score":0.48999491333961487},{"id":"https://openalex.org/C177713679","wikidata":"https://www.wikidata.org/wiki/Q679690","display_name":"Intensive care medicine","level":1,"score":0.48708319664001465},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.48639801144599915},{"id":"https://openalex.org/C2779888176","wikidata":"https://www.wikidata.org/wiki/Q412666","display_name":"Ramipril","level":3,"score":0.43570855259895325},{"id":"https://openalex.org/C2779318504","wikidata":"https://www.wikidata.org/wiki/Q1438035","display_name":"Research design","level":2,"score":0.43364885449409485},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.202191561460495},{"id":"https://openalex.org/C84393581","wikidata":"https://www.wikidata.org/wiki/Q82642","display_name":"Blood pressure","level":2,"score":0.0},{"id":"https://openalex.org/C36289849","wikidata":"https://www.wikidata.org/wiki/Q34749","display_name":"Social science","level":1,"score":0.0},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.0},{"id":"https://openalex.org/C78519656","wikidata":"https://www.wikidata.org/wiki/Q101333","display_name":"Mechanical engineering","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/C2778810321","wikidata":"https://www.wikidata.org/wiki/Q419345","display_name":"Dabigatran","level":4,"score":0.0}],"mesh":[{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D009626","descriptor_name":"Terminology as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012107","descriptor_name":"Research Design","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D016032","descriptor_name":"Randomized Controlled Trials as Topic","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D016032","descriptor_name":"Randomized Controlled Trials as Topic","qualifier_ui":"Q000592","qualifier_name":"standards","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":"D057186","descriptor_name":"Comparative Effectiveness Research","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":false},{"descriptor_ui":"D057186","descriptor_name":"Comparative Effectiveness Research","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D057186","descriptor_name":"Comparative Effectiveness Research","qualifier_ui":"Q000706","qualifier_name":"statistics & numerical data","is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.1111/j.1742-1241.2010.02481.x","doi":"https://doi.org/10.1111/j.1742-1241.2010.02481.x","is_oa":true,"landing_page_url":"https://doi.org/10.1111/j.1742-1241.2010.02481.x","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/j.1742-1241.2010.02481.x","source":{"id":"https://openalex.org/S22344484","display_name":"International Journal of Clinical Practice","issn_l":"1368-5031","issn":["1368-5031","1742-1241"],"is_oa":false,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-scientific","cwts-core","doaj","dongbi-c","doyens","jufo-1","ki-jl-1","norway-1","poland-70","russia-white-list-1","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 Clinical Practice","raw_type":"journal-article"},{"id":"pmid:20716144","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/20716144","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 clinical practice","raw_type":"Journal Article"}],"best_oa_location":{"id":"doi:10.1111/j.1742-1241.2010.02481.x","doi":"https://doi.org/10.1111/j.1742-1241.2010.02481.x","is_oa":true,"landing_page_url":"https://doi.org/10.1111/j.1742-1241.2010.02481.x","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/j.1742-1241.2010.02481.x","source":{"id":"https://openalex.org/S22344484","display_name":"International Journal of Clinical Practice","issn_l":"1368-5031","issn":["1368-5031","1742-1241"],"is_oa":false,"is_in_doaj":true,"is_core":true,"listed_in":["anvur-scientific","cwts-core","doaj","dongbi-c","doyens","jufo-1","ki-jl-1","norway-1","poland-70","russia-white-list-1","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 Clinical Practice","raw_type":"journal-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":0.9537000060081482}],"study_designs":[],"awards":[],"funders":[{"id":"https://openalex.org/F4320306257","display_name":"Boehringer Ingelheim","ror":"https://ror.org/05kffp613"}],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W1819090348.pdf","grobid_xml":"https://content.openalex.org/works/W1819090348.grobid-xml"},"referenced_works_count":20,"referenced_works":["https://openalex.org/W46469814","https://openalex.org/W1804375307","https://openalex.org/W1872884077","https://openalex.org/W1974689215","https://openalex.org/W1981637228","https://openalex.org/W2007239126","https://openalex.org/W2026766761","https://openalex.org/W2028670646","https://openalex.org/W2037910800","https://openalex.org/W2051267547","https://openalex.org/W2071126330","https://openalex.org/W2097874838","https://openalex.org/W2133417386","https://openalex.org/W2152740900","https://openalex.org/W2152798629","https://openalex.org/W2156121263","https://openalex.org/W2163815180","https://openalex.org/W2164963279","https://openalex.org/W2166797988","https://openalex.org/W2186657631"],"related_works":["https://openalex.org/W2810800710","https://openalex.org/W7097964919","https://openalex.org/W6948405684","https://openalex.org/W46469814","https://openalex.org/W2146979304","https://openalex.org/W1985638561","https://openalex.org/W3170430205","https://openalex.org/W3015495004","https://openalex.org/W4407044623","https://openalex.org/W7125594388"],"abstract_inverted_index":{"Every":[0],"year,":[1],"results":[2,26],"from":[3,109],"many":[4],"important":[5,28],"randomised,":[6,64,144],"controlled":[7,65],"trials":[8,113,212,227],"are":[9,27],"published.":[10],"Knowing":[11],"the":[12,19,42,80,94,148,199,202,205,255],"elements":[13],"of":[14,34,44,62,107,126,132,150,156,184,201,222],"trial":[15,45,146],"design":[16,118,217],"and":[17,24,70,93,98,111,119,122,158,167,208,232,240,247,259],"having":[18],"skills":[20],"to":[21,29,38,47,214,261],"critically":[22],"read":[23],"incorporate":[25],"medical":[30,54],"practitioners.":[31],"The":[32],"goal":[33],"this":[35],"article":[36,58],"is":[37],"help":[39],"physicians":[40],"determine":[41],"validity":[43],"conclusions":[46,221],"improve":[48],"patient":[49,257],"care":[50],"through":[51],"more":[52],"informed":[53],"decision":[55],"making.":[56],"This":[57],"includes":[59,137],"a":[60,138],"review":[61],"162":[63],"non-inferiority":[66,226],"(n":[67,72,140],"=":[68,73,141],"116)":[69],"equivalence":[71],"46)":[74],"hypothesis":[75],"studies":[76],"as":[77,79,190,192],"well":[78,191],"larger":[81],"Stroke":[82],"Prevention":[83],"using":[84],"Oral":[85],"Thrombin":[86],"Inhibitor":[87],"in":[88,99,117,161,188,198,220],"atrial":[89,165],"Fibrillation":[90],"V":[91],"study":[92,134],"Ongoing":[95],"Telmisartan":[96],"Alone":[97],"Combination":[100],"with":[101,152,163,179],"Ramipril":[102],"Global":[103],"Endpoint":[104],"Trial.":[105],"Evaluation":[106],"data":[108,231],"small":[110],"large":[112,139],"uncovers":[114],"significant":[115],"flaws":[116],"models":[120],"employed":[121],"uncertainty":[123],"about":[124,194],"calculations":[125],"statistical":[127],"measures.":[128],"As":[129],"one":[130],"example":[131],"questionable":[133,223],"design,":[135,189],"discussion":[136],"3922),":[142],"double-blind,":[143],"multicentre":[145],"comparing":[147],"efficacy":[149,234],"ximelagatran":[151,175],"warfarin":[153,181],"for":[154,182,235,251],"prevention":[155,183],"stroke":[157,169],"systemic":[159],"embolism":[160],"patients":[162],"non-valvular":[164],"fibrillation":[166],"additional":[168],"risk":[170],"factors.":[171],"Investigators":[172],"concluded":[173],"that":[174],"was":[176],"effective":[177],"compared":[178],"well-controlled":[180],"thromboembolism.":[185],"However,":[186],"deficiencies":[187],"concerns":[193],"liver":[195],"toxicity,":[196],"resulted":[197],"rejection":[200],"drug":[203],"by":[204],"US":[206],"Food":[207],"Drug":[209],"Administration.":[210],"Many":[211],"fail":[213],"follow":[215],"good":[216],"principles,":[218],"resulting":[219],"validity.":[224],"Well-designed":[225],"can":[228],"provide":[229],"valuable":[230],"demonstrate":[233],"beneficial":[236],"new":[237],"therapies.":[238],"Objectives":[239],"primary":[241],"end-points":[242],"must":[243],"be":[244],"clearly":[245],"stated":[246],"rigorous":[248],"standards":[249],"met":[250],"sample":[252],"size,":[253],"establishing":[254],"margin,":[256],"characteristics":[258],"adherence":[260],"protocol.":[262]},"counts_by_year":[{"year":2019,"cited_by_count":2},{"year":2014,"cited_by_count":1},{"year":2013,"cited_by_count":1}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2016-06-24T00:00:00"}
