{"id":"https://openalex.org/W1968355594","doi":"https://doi.org/10.1002/sim.3123","title":"Proper inference from Simon's two\u2010stage designs","display_name":"Proper inference from Simon's two\u2010stage designs","publication_year":2007,"publication_date":"2007-10-25","ids":{"openalex":"https://openalex.org/W1968355594","doi":"https://doi.org/10.1002/sim.3123","mag":"1968355594","pmid":"https://pubmed.ncbi.nlm.nih.gov/17960777"},"language":"en","primary_location":{"id":"doi:10.1002/sim.3123","doi":"https://doi.org/10.1002/sim.3123","is_oa":false,"landing_page_url":"https://doi.org/10.1002/sim.3123","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","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/6047527","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5048600723","display_name":"Tatsuki Koyama","orcid":"https://orcid.org/0000-0002-8908-9165","observed_orcids":["https://orcid.org/0000-0002-8908-9165"]},"institutions":[{"id":"https://openalex.org/I200719446","display_name":"Vanderbilt University","ror":"https://ror.org/02vm5rt34","country_code":"US","type":"education","lineage":["https://openalex.org/I200719446"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Tatsuki Koyama","raw_affiliation_strings":["Department of Biostatistics, Vanderbilt University School of Medicine, 571 Preston Building, Nashville, TN 37232-6848, USA. tatsuki.koyama@vanderbilt.edu","Department of Biostatistics, Vanderbilt University School of Medicine, 571 Preston Building, Nashville, TN 37232-6848, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Biostatistics, Vanderbilt University School of Medicine, 571 Preston Building, Nashville, TN 37232-6848, USA. tatsuki.koyama@vanderbilt.edu","institution_ids":["https://openalex.org/I200719446"]},{"raw_affiliation_string":"Department of Biostatistics, Vanderbilt University School of Medicine, 571 Preston Building, Nashville, TN 37232-6848, USA","institution_ids":["https://openalex.org/I200719446"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5013004380","display_name":"Heidi Chen","orcid":"https://orcid.org/0000-0002-1841-6747","observed_orcids":["https://orcid.org/0000-0002-1841-6747"]},"institutions":[{"id":"https://openalex.org/I200719446","display_name":"Vanderbilt University","ror":"https://ror.org/02vm5rt34","country_code":"US","type":"education","lineage":["https://openalex.org/I200719446"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Heidi Chen","raw_affiliation_strings":["Department of Biostatistics, Vanderbilt University School of Medicine, 571 Preston Building, Nashville, TN 37232-6848, U.S.A","Department of Biostatistics, Vanderbilt University School of Medicine, 571 Preston Building, Nashville, TN 37232\u20106848, U.S.A"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Biostatistics, Vanderbilt University School of Medicine, 571 Preston Building, Nashville, TN 37232-6848, U.S.A","institution_ids":["https://openalex.org/I200719446"]},{"raw_affiliation_string":"Department of Biostatistics, Vanderbilt University School of Medicine, 571 Preston Building, Nashville, TN 37232\u20106848, U.S.A","institution_ids":["https://openalex.org/I200719446"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5048600723"],"corresponding_institution_ids":["https://openalex.org/I200719446"],"apc_list":{"value":5450,"currency":"USD","value_usd":5450},"apc_paid":null,"fwci":2.0892,"has_fulltext":false,"cited_by_count":135,"citation_normalized_percentile":{"value":0.88117014,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":94,"max":100},"biblio":{"volume":"27","issue":"16","first_page":"3145","last_page":"3154"},"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/simon-s-two-stage-design","display_name":"Simon two-stage design","score":0.8989999890327454},{"id":"https://openalex.org/keywords/adaptive-design","display_name":"adaptive design","score":0.5979999899864197},{"id":"https://openalex.org/keywords/inference-procedures","display_name":"inference procedures","score":0.49799999594688416},{"id":"https://openalex.org/keywords/confidence-intervals","display_name":"confidence intervals","score":0.902999997138977},{"id":"https://openalex.org/keywords/p-values","display_name":"p-values","score":0.9520000219345093},{"id":"https://openalex.org/keywords/sample-size-adjustment","display_name":"sample size adjustment","score":0.6990000009536743},{"id":"https://openalex.org/keywords/hypothesis-testing","display_name":"hypothesis testing","score":0.828000009059906}],"concepts":[{"id":"https://openalex.org/C2776214188","wikidata":"https://www.wikidata.org/wiki/Q408386","display_name":"Inference","level":2,"score":0.7394472360610962},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.638238787651062},{"id":"https://openalex.org/C146357865","wikidata":"https://www.wikidata.org/wiki/Q1123245","display_name":"Stage (stratigraphy)","level":2,"score":0.4105088710784912},{"id":"https://openalex.org/C149782125","wikidata":"https://www.wikidata.org/wiki/Q160039","display_name":"Econometrics","level":1,"score":0.37511971592903137},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.3700757622718811},{"id":"https://openalex.org/C154945302","wikidata":"https://www.wikidata.org/wiki/Q11660","display_name":"Artificial intelligence","level":1,"score":0.3662220239639282},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.21429723501205444},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.06305989623069763},{"id":"https://openalex.org/C151730666","wikidata":"https://www.wikidata.org/wiki/Q7205","display_name":"Paleontology","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D006801","descriptor_name":"Humans","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":"D006801","descriptor_name":"Humans","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":"D012107","descriptor_name":"Research Design","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D012107","descriptor_name":"Research Design","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D015233","descriptor_name":"Models, Statistical","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D015233","descriptor_name":"Models, Statistical","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D015233","descriptor_name":"Models, Statistical","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D017322","descriptor_name":"Clinical Trials, Phase II as Topic","qualifier_ui":"Q000706","qualifier_name":"statistics & numerical data","is_major_topic":false},{"descriptor_ui":"D017322","descriptor_name":"Clinical Trials, Phase II as Topic","qualifier_ui":"Q000706","qualifier_name":"statistics & numerical data","is_major_topic":false},{"descriptor_ui":"D017322","descriptor_name":"Clinical Trials, Phase II as Topic","qualifier_ui":"Q000706","qualifier_name":"statistics & numerical data","is_major_topic":false},{"descriptor_ui":"D018401","descriptor_name":"Sample Size","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":"D018401","descriptor_name":"Sample Size","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":4,"locations":[{"id":"doi:10.1002/sim.3123","doi":"https://doi.org/10.1002/sim.3123","is_oa":false,"landing_page_url":"https://doi.org/10.1002/sim.3123","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:17960777","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/17960777","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":"Journal Article"},{"id":"pmh:oai:europepmc.org:5000882","doi":null,"is_oa":false,"landing_page_url":"http://europepmc.org/pmc/articles/PMC6047527","pdf_url":null,"source":{"id":"https://openalex.org/S4306400806","display_name":"Europe PMC (PubMed Central)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1303153112","host_organization_name":"European Bioinformatics Institute","host_organization_lineage":["https://openalex.org/I1303153112"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"","raw_type":"Text"},{"id":"pmh:oai:pubmedcentral.nih.gov:6047527","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/6047527","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,"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":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Stat Med","raw_type":"Text"}],"best_oa_location":{"id":"pmh:oai:pubmedcentral.nih.gov:6047527","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/6047527","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,"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":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Stat Med","raw_type":"Text"},"sustainable_development_goals":[],"sustainable_development_goals_aurora":[],"study_designs":[],"awards":[{"id":"https://openalex.org/G725763919","display_name":null,"funder_award_id":"P30 CA 068485","funder_id":"https://openalex.org/F4320337351","funder_display_name":"National Cancer Institute"}],"funders":[{"id":"https://openalex.org/F4320337351","display_name":"National Cancer Institute","ror":"https://ror.org/040gcmg81"}],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":32,"referenced_works":["https://openalex.org/W1571725767","https://openalex.org/W1967011174","https://openalex.org/W1970804828","https://openalex.org/W1974898716","https://openalex.org/W1976585131","https://openalex.org/W1978294852","https://openalex.org/W1980032822","https://openalex.org/W1984458529","https://openalex.org/W1985729969","https://openalex.org/W1987066512","https://openalex.org/W1988952766","https://openalex.org/W1990455158","https://openalex.org/W1992419102","https://openalex.org/W2029409133","https://openalex.org/W2032776661","https://openalex.org/W2044200030","https://openalex.org/W2048381381","https://openalex.org/W2053990449","https://openalex.org/W2067443509","https://openalex.org/W2068558212","https://openalex.org/W2068978713","https://openalex.org/W2078270553","https://openalex.org/W2124462125","https://openalex.org/W2131503836","https://openalex.org/W2140556790","https://openalex.org/W2140753559","https://openalex.org/W2148507548","https://openalex.org/W2162102022","https://openalex.org/W2166904052","https://openalex.org/W2316222558","https://openalex.org/W2328166842","https://openalex.org/W2963287295"],"related_works":["https://openalex.org/W2503350049","https://openalex.org/W2329386257","https://openalex.org/W2055243143","https://openalex.org/W2005585032","https://openalex.org/W2397616145","https://openalex.org/W1988477118","https://openalex.org/W4324058133","https://openalex.org/W2397320258","https://openalex.org/W648618910","https://openalex.org/W2555803316"],"abstract_inverted_index":{"Simon's":[0,21],"two-stage":[1],"designs":[2,22],"are":[3,42],"very":[4],"popular":[5],"for":[6,38,46,59,74,99],"phase":[7],"II":[8],"clinical":[9],"trials.":[10],"A":[11],"literature":[12],"review":[13],"revealed":[14],"that":[15,54,67],"the":[16,26,39,47,55,60,78,81,88,100,109,112],"inference":[17,90],"procedures":[18,91],"used":[19],"with":[20],"almost":[23],"always":[24],"ignore":[25],"actual":[27,56,82],"sampling":[28],"plan":[29],"used.":[30],"Reported":[31],"P-values,":[32],"point":[33],"estimates":[34],"and":[35,80,87,96],"confidence":[36,97],"intervals":[37,98],"response":[40,101],"rate":[41],"not":[43],"usually":[44,92],"adjusted":[45],"design's":[48],"adaptiveness.":[49],"In":[50],"addition,":[51],"we":[52],"found":[53],"sample":[57,83],"size":[58],"second":[61],"stage":[62],"is":[63],"often":[64],"different":[65],"from":[66],"planned.":[68],"We":[69],"present":[70],"here":[71],"a":[72],"method":[73],"inferences":[75],"using":[76],"both":[77],"planned":[79],"sizes.":[84],"The":[85,103],"conventional":[86,104],"preferred":[89],"yield":[93],"similar":[94],"P-values":[95],"rate.":[102],"inference,":[105],"however,":[106],"may":[107],"contradict":[108],"result":[110],"of":[111],"corresponding":[113],"hypothesis":[114],"testing.":[115]},"counts_by_year":[{"year":2026,"cited_by_count":9},{"year":2025,"cited_by_count":8},{"year":2024,"cited_by_count":13},{"year":2023,"cited_by_count":17},{"year":2022,"cited_by_count":13},{"year":2021,"cited_by_count":13},{"year":2020,"cited_by_count":10},{"year":2019,"cited_by_count":3},{"year":2018,"cited_by_count":6},{"year":2017,"cited_by_count":5},{"year":2016,"cited_by_count":3},{"year":2015,"cited_by_count":10},{"year":2014,"cited_by_count":3},{"year":2013,"cited_by_count":2},{"year":2012,"cited_by_count":6}],"updated_date":"2026-10-08T09:06:37.294493","created_date":"2025-10-10T00:00:00"}