{"id":"https://openalex.org/W1976558163","doi":"https://doi.org/10.1002/sim.1450","title":"Assessing non\u2010inferiority of a new treatment in a three\u2010arm clinical trial including a placebo","display_name":"Assessing non\u2010inferiority of a new treatment in a three\u2010arm clinical trial including a placebo","publication_year":2003,"publication_date":"2003-02-21","ids":{"openalex":"https://openalex.org/W1976558163","doi":"https://doi.org/10.1002/sim.1450","mag":"1976558163","pmid":"https://pubmed.ncbi.nlm.nih.gov/12627407"},"language":"en","primary_location":{"id":"doi:10.1002/sim.1450","doi":"https://doi.org/10.1002/sim.1450","is_oa":false,"landing_page_url":"https://doi.org/10.1002/sim.1450","pdf_url":null,"source":{"id":"https://openalex.org/S55189604","display_name":"Statistics in Medicine","issn_l":"0277-6715","issn":["0277-6715","1097-0258"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["abdc-a","anvur-class-a","anvur-scientific","cwts-core","dongbi-b","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-100","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":"Statistics in Medicine","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"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/A5033855594","display_name":"Iris Pigeot","orcid":"https://orcid.org/0000-0001-7483-0726","observed_orcids":["https://orcid.org/0000-0001-7483-0726"]},"institutions":[{"id":"https://openalex.org/I180437899","display_name":"University of Bremen","ror":"https://ror.org/04ers2y35","country_code":"DE","type":"education","lineage":["https://openalex.org/I180437899"]},{"id":"https://openalex.org/I4210113759","display_name":"Leibniz Institute for Prevention Research and Epidemiology - BIPS","ror":"https://ror.org/02c22vc57","country_code":"DE","type":"facility","lineage":["https://openalex.org/I315704651","https://openalex.org/I4210113759"]}],"countries":["DE"],"is_corresponding":true,"raw_author_name":"Iris Pigeot","raw_affiliation_strings":["Institute of Statistics, University of Bremen, Postfach 330440, 28334 Bremen, Germany. pigeot@bips.uni-bremen.de","Bremen Institute for Prevention Research and Social Medicine, Linzer Str. 8-10, 28359 Bremen, Germany","Institute of Statistics, University of Bremen, Postfach 330440, 28334 Bremen, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Institute of Statistics, University of Bremen, Postfach 330440, 28334 Bremen, Germany. pigeot@bips.uni-bremen.de","institution_ids":["https://openalex.org/I180437899"]},{"raw_affiliation_string":"Bremen Institute for Prevention Research and Social Medicine, Linzer Str. 8-10, 28359 Bremen, Germany","institution_ids":["https://openalex.org/I4210113759"]},{"raw_affiliation_string":"Institute of Statistics, University of Bremen, Postfach 330440, 28334 Bremen, Germany","institution_ids":["https://openalex.org/I180437899"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5084415401","display_name":"Juliane Sch\u00e4fer","orcid":"https://orcid.org/0000-0002-7466-5959","observed_orcids":["https://orcid.org/0000-0002-7466-5959"]},"institutions":[{"id":"https://openalex.org/I8204097","display_name":"Ludwig-Maximilians-Universit\u00e4t M\u00fcnchen","ror":"https://ror.org/05591te55","country_code":"DE","type":"education","lineage":["https://openalex.org/I8204097"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Juliane Sch\u00e4fer","raw_affiliation_strings":["Institute of Statistics, University of Munich, Ludwigstr. 33, 80539 Munich, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Institute of Statistics, University of Munich, Ludwigstr. 33, 80539 Munich, Germany","institution_ids":["https://openalex.org/I8204097"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5067919581","display_name":"Joachim R\u00f6hmel","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I123859907","display_name":"Federal Institute for Drugs and Medical Devices","ror":"https://ror.org/05ex5vz81","country_code":"DE","type":"funder","lineage":["https://openalex.org/I123859907"]}],"countries":["DE"],"is_corresponding":false,"raw_author_name":"Joachim R\u00f6hmel","raw_affiliation_strings":["Federal Institute for Drugs and Medical Devices, Friedrich-Ebert-Allee 38, 53113 Bonn, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Federal Institute for Drugs and Medical Devices, Friedrich-Ebert-Allee 38, 53113 Bonn, Germany","institution_ids":["https://openalex.org/I123859907"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5024998348","display_name":"Dieter Hauschke","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Dieter Hauschke","raw_affiliation_strings":["Department of Biometry, ALTANA Pharma AG, Byk-Gulden-Str. 2, 78467 Konstanz, Germany"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Biometry, ALTANA Pharma AG, Byk-Gulden-Str. 2, 78467 Konstanz, Germany","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":4,"corresponding_author_ids":["https://openalex.org/A5033855594"],"corresponding_institution_ids":["https://openalex.org/I180437899","https://openalex.org/I4210113759"],"apc_list":{"value":5450,"currency":"USD","value_usd":5450},"apc_paid":null,"fwci":6.6952,"has_fulltext":false,"cited_by_count":139,"citation_normalized_percentile":{"value":0.97584489,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":96,"max":99},"biblio":{"volume":"22","issue":"6","first_page":"883","last_page":"899"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":1.0,"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":1.0,"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/T13500","display_name":"Probability and Statistical Research","score":0.0,"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/T10243","display_name":"Statistical Methods and Bayesian Inference","score":0.0,"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/non-inferiority","display_name":"non-inferiority","score":0.8809999823570251},{"id":"https://openalex.org/keywords/placebo-group","display_name":"placebo group","score":0.640999972820282},{"id":"https://openalex.org/keywords/internal-validation","display_name":"internal validation","score":0.7919999957084656},{"id":"https://openalex.org/keywords/power-function","display_name":"power function","score":0.8560000061988831},{"id":"https://openalex.org/keywords/sample-size-calculation","display_name":"sample size determination","score":0.9919999837875366},{"id":"https://openalex.org/keywords/optimal-allocation","display_name":"optimal allocation","score":0.6949999928474426},{"id":"https://openalex.org/keywords/mild-asthma","display_name":"mild asthma","score":0.546999990940094}],"concepts":[{"id":"https://openalex.org/C44249647","wikidata":"https://www.wikidata.org/wiki/Q208498","display_name":"Confidence interval","level":2,"score":0.7587530016899109},{"id":"https://openalex.org/C129848803","wikidata":"https://www.wikidata.org/wiki/Q2564360","display_name":"Sample size determination","level":2,"score":0.6619824171066284},{"id":"https://openalex.org/C122048520","wikidata":"https://www.wikidata.org/wiki/Q2913954","display_name":"Percentile","level":2,"score":0.6543198823928833},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.6108726859092712},{"id":"https://openalex.org/C27081682","wikidata":"https://www.wikidata.org/wiki/Q269829","display_name":"Placebo","level":3,"score":0.5361710786819458},{"id":"https://openalex.org/C2776157432","wikidata":"https://www.wikidata.org/wiki/Q1375683","display_name":"Normality","level":2,"score":0.5349951982498169},{"id":"https://openalex.org/C117251300","wikidata":"https://www.wikidata.org/wiki/Q1849855","display_name":"Parametric statistics","level":2,"score":0.4700671136379242},{"id":"https://openalex.org/C42404028","wikidata":"https://www.wikidata.org/wiki/Q864940","display_name":"Bioequivalence","level":3,"score":0.44133979082107544},{"id":"https://openalex.org/C142259097","wikidata":"https://www.wikidata.org/wiki/Q5891314","display_name":"Homogeneity (statistics)","level":2,"score":0.43870770931243896},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.41796454787254333},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.3989476263523102},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.12383988499641418},{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.08402925729751587},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.0},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D001249","descriptor_name":"Asthma","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":false},{"descriptor_ui":"D003627","descriptor_name":"Data Interpretation, Statistical","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D009716","descriptor_name":"Numerical Analysis, Computer-Assisted","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012107","descriptor_name":"Research Design","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D013810","descriptor_name":"Therapeutic Equivalency","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D014797","descriptor_name":"Vital Capacity","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016001","descriptor_name":"Confidence Intervals","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D018401","descriptor_name":"Sample Size","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D018849","descriptor_name":"Controlled Clinical Trials as Topic","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D018927","descriptor_name":"Anti-Asthmatic Agents","qualifier_ui":"Q000627","qualifier_name":"therapeutic use","is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.1002/sim.1450","doi":"https://doi.org/10.1002/sim.1450","is_oa":false,"landing_page_url":"https://doi.org/10.1002/sim.1450","pdf_url":null,"source":{"id":"https://openalex.org/S55189604","display_name":"Statistics in Medicine","issn_l":"0277-6715","issn":["0277-6715","1097-0258"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["abdc-a","anvur-class-a","anvur-scientific","cwts-core","dongbi-b","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-100","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":"Statistics in Medicine","raw_type":"journal-article"},{"id":"pmid:12627407","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/12627407","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":"Statistics in medicine","raw_type":"Comparative Study"}],"best_oa_location":null,"sustainable_development_goals":[{"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3","score":0.5683000087738037}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":12,"referenced_works":["https://openalex.org/W1958971206","https://openalex.org/W1995945562","https://openalex.org/W2083765816","https://openalex.org/W2112022331","https://openalex.org/W2150575977","https://openalex.org/W2163332530","https://openalex.org/W2164322424","https://openalex.org/W2527882685","https://openalex.org/W2605882613","https://openalex.org/W3106889297","https://openalex.org/W4230929665","https://openalex.org/W4253686430"],"related_works":["https://openalex.org/W2006993335","https://openalex.org/W2038214292","https://openalex.org/W2854382114","https://openalex.org/W2528741121","https://openalex.org/W2020625837","https://openalex.org/W2123270919","https://openalex.org/W2390821084","https://openalex.org/W2152789282","https://openalex.org/W1983885983","https://openalex.org/W3108799477"],"abstract_inverted_index":{"In":[0],"non-inferiority":[1,4],"trials,":[2],"where":[3],"of":[5,37,48,76,94],"a":[6,53,87,122],"new":[7],"experimental":[8],"drug":[9],"compared":[10,116],"to":[11,16,23,60,63,85,104],"an":[12,25,102],"active":[13],"control":[14],"has":[15],"be":[17,21,61],"shown,":[18],"it":[19],"may":[20],"advisable":[22],"use":[24],"additional":[26],"placebo":[27],"group":[28],"for":[29],"internal":[30],"validation":[31],"if":[32],"ethically":[33],"justifiable.":[34],"The":[35],"focus":[36],"this":[38,77,105],"paper":[39],"is":[40,99,112],"on":[41,67,72,124],"such":[42],"designs.":[43],"Assuming":[44],"normality":[45],"and":[46,114],"homogeneity":[47],"variances":[49],"we":[50],"will":[51],"derive":[52],"statistical":[54],"test":[55],"procedure":[56],"which":[57],"turns":[58],"out":[59,84],"equivalent":[62],"the":[64,73,91,95,108],"assessment":[65],"based":[66],"Fieller's":[68,118],"confidence":[69,119],"interval.":[70],"Based":[71],"power":[74],"function":[75],"test,":[78],"sample":[79,97],"size":[80,98],"calculations":[81],"are":[82],"carried":[83],"achieve":[86],"given":[88],"power.":[89],"Additionally,":[90],"optimal":[92],"allocation":[93],"total":[96],"derived.":[100],"As":[101],"alternative":[103],"parametric":[106],"procedure,":[107],"bootstrap":[109],"percentile":[110],"interval":[111,120],"discussed":[113],"finally":[115],"with":[117],"in":[121],"study":[123],"mildly":[125],"asthmatic":[126],"patients.":[127]},"counts_by_year":[{"year":2026,"cited_by_count":7},{"year":2025,"cited_by_count":4},{"year":2024,"cited_by_count":5},{"year":2023,"cited_by_count":6},{"year":2022,"cited_by_count":8},{"year":2021,"cited_by_count":4},{"year":2020,"cited_by_count":7},{"year":2019,"cited_by_count":5},{"year":2018,"cited_by_count":3},{"year":2017,"cited_by_count":3},{"year":2016,"cited_by_count":9},{"year":2015,"cited_by_count":6},{"year":2014,"cited_by_count":7},{"year":2013,"cited_by_count":5},{"year":2012,"cited_by_count":8}],"updated_date":"2026-11-07T11:25:07.637180","created_date":"2016-06-24T00:00:00"}
