{"id":"https://openalex.org/W2140753559","doi":"https://doi.org/10.1002/sim.2188","title":"A design of phase II cancer trials using total and complete response endpoints","display_name":"A design of phase II cancer trials using total and complete response endpoints","publication_year":2005,"publication_date":"2005-09-27","ids":{"openalex":"https://openalex.org/W2140753559","doi":"https://doi.org/10.1002/sim.2188","mag":"2140753559","pmid":"https://pubmed.ncbi.nlm.nih.gov/16189806"},"language":"en","primary_location":{"id":"doi:10.1002/sim.2188","doi":"https://doi.org/10.1002/sim.2188","is_oa":false,"landing_page_url":"https://doi.org/10.1002/sim.2188","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/A5057666375","display_name":"Ying L\u00fc","orcid":"https://orcid.org/0000-0002-7698-8962","observed_orcids":["https://orcid.org/0000-0002-7698-8962","https://orcid.org/0000-0001-7420-0206"]},"institutions":[{"id":"https://openalex.org/I180670191","display_name":"University of California, San Francisco","ror":"https://ror.org/043mz5j54","country_code":"US","type":"education","lineage":["https://openalex.org/I180670191"]},{"id":"https://openalex.org/I4210167126","display_name":"UCSF Helen Diller Family Comprehensive Cancer Center","ror":"https://ror.org/05yndxy10","country_code":"US","type":"facility","lineage":["https://openalex.org/I180670191","https://openalex.org/I4210110664","https://openalex.org/I4210167126"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Ying Lu","raw_affiliation_strings":["Biostatistics Core, UCSF Comprehensive Cancer Center, USA. ying.lu@radiology.ucsf.edu","Biostatistics Core, UCSF Comprehensive Cancer Center, U.S.A","Department of Epidemiology and Biostatistics, University of California, San Francisco, CA 94143-0946, U.S.A","Department of Radiology, Box 0946, University of California, San Francisco, CA 94143-0946, U.S.A"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Biostatistics Core, UCSF Comprehensive Cancer Center, USA. ying.lu@radiology.ucsf.edu","institution_ids":["https://openalex.org/I180670191"]},{"raw_affiliation_string":"Biostatistics Core, UCSF Comprehensive Cancer Center, U.S.A","institution_ids":["https://openalex.org/I180670191","https://openalex.org/I4210167126"]},{"raw_affiliation_string":"Department of Epidemiology and Biostatistics, University of California, San Francisco, CA 94143-0946, U.S.A","institution_ids":["https://openalex.org/I180670191"]},{"raw_affiliation_string":"Department of Radiology, Box 0946, University of California, San Francisco, CA 94143-0946, U.S.A","institution_ids":["https://openalex.org/I180670191"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5101717159","display_name":"Hua Jin","orcid":"https://orcid.org/0000-0001-9485-0249","observed_orcids":["https://orcid.org/0000-0001-9485-0249","https://orcid.org/0009-0006-9121-2149","https://orcid.org/0009-0009-2491-7829"]},"institutions":[{"id":"https://openalex.org/I180670191","display_name":"University of California, San Francisco","ror":"https://ror.org/043mz5j54","country_code":"US","type":"education","lineage":["https://openalex.org/I180670191"]},{"id":"https://openalex.org/I20231570","display_name":"Peking University","ror":"https://ror.org/02v51f717","country_code":"CN","type":"education","lineage":["https://openalex.org/I20231570"]}],"countries":["CN","US"],"is_corresponding":false,"raw_author_name":"Hua Jin","raw_affiliation_strings":["Department of Probability and Statistics, Peking University, Beijing 100871, China","Department of Radiology, Box 0946, University of California, San Francisco, CA 94143-0946, U.S.A"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Probability and Statistics, Peking University, Beijing 100871, China","institution_ids":["https://openalex.org/I20231570"]},{"raw_affiliation_string":"Department of Radiology, Box 0946, University of California, San Francisco, CA 94143-0946, U.S.A","institution_ids":["https://openalex.org/I180670191"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5061018141","display_name":"Kathleen R. Lamborn","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I180670191","display_name":"University of California, San Francisco","ror":"https://ror.org/043mz5j54","country_code":"US","type":"education","lineage":["https://openalex.org/I180670191"]},{"id":"https://openalex.org/I4210167126","display_name":"UCSF Helen Diller Family Comprehensive Cancer Center","ror":"https://ror.org/05yndxy10","country_code":"US","type":"facility","lineage":["https://openalex.org/I180670191","https://openalex.org/I4210110664","https://openalex.org/I4210167126"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Kathleen R. Lamborn","raw_affiliation_strings":["Biostatistics Core, UCSF Comprehensive Cancer Center, U.S.A","Department of Epidemiology and Biostatistics, University of California, San Francisco, CA 94143-0946, U.S.A","Department of Neurological Surgery, University of California, San Francisco, CA 94143-0372, U.S.A"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Biostatistics Core, UCSF Comprehensive Cancer Center, U.S.A","institution_ids":["https://openalex.org/I180670191","https://openalex.org/I4210167126"]},{"raw_affiliation_string":"Department of Epidemiology and Biostatistics, University of California, San Francisco, CA 94143-0946, U.S.A","institution_ids":["https://openalex.org/I180670191"]},{"raw_affiliation_string":"Department of Neurological Surgery, University of California, San Francisco, CA 94143-0372, U.S.A","institution_ids":["https://openalex.org/I180670191"]}]}],"institutions":[],"countries_distinct_count":2,"institutions_distinct_count":3,"corresponding_author_ids":["https://openalex.org/A5057666375"],"corresponding_institution_ids":["https://openalex.org/I180670191","https://openalex.org/I4210167126"],"apc_list":{"value":5450,"currency":"USD","value_usd":5450},"apc_paid":null,"fwci":1.9456,"has_fulltext":false,"cited_by_count":31,"citation_normalized_percentile":{"value":0.87884806,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":97},"biblio":{"volume":"24","issue":"20","first_page":"3155","last_page":"3170"},"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":0.8199999928474426},{"id":"https://openalex.org/keywords/complete-response","display_name":"complete response","score":0.8989999890327454},{"id":"https://openalex.org/keywords/partial-response","display_name":"partial response","score":0.996999979019165},{"id":"https://openalex.org/keywords/sample-size-calculation","display_name":"sample size determination","score":0.9110000133514404},{"id":"https://openalex.org/keywords/trinomial-model","display_name":"trinomial model","score":0.7889999747276306},{"id":"https://openalex.org/keywords/glioblastoma","display_name":"glioblastoma","score":0.753000020980835},{"id":"https://openalex.org/keywords/stable-disease","display_name":"stable disease","score":0.5830000042915344},{"id":"https://openalex.org/keywords/treatment-efficacy-evaluation","display_name":"treatment efficacy assessment","score":0.4699999988079071}],"concepts":[{"id":"https://openalex.org/C3019096185","wikidata":"https://www.wikidata.org/wiki/Q1340863","display_name":"Complete response","level":3,"score":0.5211270451545715},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.5157466530799866},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.5147995352745056},{"id":"https://openalex.org/C129848803","wikidata":"https://www.wikidata.org/wiki/Q2564360","display_name":"Sample size determination","level":2,"score":0.48097479343414307},{"id":"https://openalex.org/C2780598303","wikidata":"https://www.wikidata.org/wiki/Q65921492","display_name":"Flexibility (engineering)","level":2,"score":0.47001245617866516},{"id":"https://openalex.org/C146357865","wikidata":"https://www.wikidata.org/wiki/Q1123245","display_name":"Stage (stratigraphy)","level":2,"score":0.46059927344322205},{"id":"https://openalex.org/C31760486","wikidata":"https://www.wikidata.org/wiki/Q7180990","display_name":"Phases of clinical research","level":3,"score":0.446489542722702},{"id":"https://openalex.org/C2781413609","wikidata":"https://www.wikidata.org/wiki/Q7308373","display_name":"Regimen","level":2,"score":0.44207918643951416},{"id":"https://openalex.org/C143998085","wikidata":"https://www.wikidata.org/wiki/Q162555","display_name":"Oncology","level":1,"score":0.3743807375431061},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.36798620223999023},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.3334347605705261},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.3303631544113159},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.2965615391731262},{"id":"https://openalex.org/C2776694085","wikidata":"https://www.wikidata.org/wiki/Q974135","display_name":"Chemotherapy","level":2,"score":0.20444068312644958},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.0},{"id":"https://openalex.org/C151730666","wikidata":"https://www.wikidata.org/wiki/Q7205","display_name":"Paleontology","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D000970","descriptor_name":"Antineoplastic Agents","qualifier_ui":"Q000627","qualifier_name":"therapeutic use","is_major_topic":false},{"descriptor_ui":"D001932","descriptor_name":"Brain Neoplasms","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":false},{"descriptor_ui":"D005909","descriptor_name":"Glioblastoma","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":false},{"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":false},{"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":"Q000379","qualifier_name":"methods","is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.1002/sim.2188","doi":"https://doi.org/10.1002/sim.2188","is_oa":false,"landing_page_url":"https://doi.org/10.1002/sim.2188","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:16189806","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/16189806","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"}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.8371999859809875,"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being"}],"study_designs":[],"awards":[{"id":"https://openalex.org/G9000868711","display_name":"Cancer Center Support Grant","funder_award_id":"P30CA082103","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":10,"referenced_works":["https://openalex.org/W1967011174","https://openalex.org/W1987066512","https://openalex.org/W1989339760","https://openalex.org/W2029409133","https://openalex.org/W2060727156","https://openalex.org/W2074887877","https://openalex.org/W2095069804","https://openalex.org/W2121029321","https://openalex.org/W2156484969","https://openalex.org/W2335819641"],"related_works":["https://openalex.org/W1987066512","https://openalex.org/W1970738201","https://openalex.org/W2091341372","https://openalex.org/W2068113261","https://openalex.org/W2077102720","https://openalex.org/W2150513161","https://openalex.org/W1967011174","https://openalex.org/W2520311791","https://openalex.org/W2081367546","https://openalex.org/W622627991"],"abstract_inverted_index":{"Phase":[0],"II":[1,154,184],"clinical":[2],"trials":[3],"in":[4,198,256],"oncology":[5],"are":[6],"used":[7,31,117],"for":[8,32,129,186],"initial":[9],"evaluation":[10],"of":[11,15,55,68,91,104,108,181,209,219,228,236],"the":[12,101,105,114,169,229,234,240,248],"therapeutic":[13],"efficacy":[14,143],"a":[16,81,88,97,118,126,182],"new":[17,150],"treatment":[18,188],"regimen.":[19],"Simon's":[20],"two-stage":[21,151,243],"design":[22,83,156,232,244],"based":[23,86,144,157],"on":[24,73,87,113,145,158,167,175],"total":[25],"response":[26,44,48,58,62],"(TR)":[27],"rate":[28],"is":[29,85,162,189],"commonly":[30],"such":[33],"trials.":[34],"Several":[35],"authors":[36],"have":[37,70],"proposed":[38,80],"alternative":[39],"strategies":[40],"to":[41,99,124,141,239,250],"consider":[42,125],"either":[43,199],"and":[45,49,60,64,78,93,111,121,131,147,160,171,174,214,254],"toxicity":[46],"or":[47,204,222],"early":[50],"progression.":[51],"Because":[52],"TR":[53,146,159],"consists":[54],"both":[56],"partial":[57],"(PR)":[59],"complete":[61],"(CR)":[63],"these":[65],"two":[66,106],"types":[67],"responses":[69,252],"different":[71],"effects":[72],"subsequent":[74],"patient":[75],"outcome,":[76],"Lin":[77],"Chen":[79],"flexible":[82],"that":[84],"weighted":[89],"average":[90],"PR":[92,130,213,221],"CR":[94,132,161,205,215,223,255],"rates":[95],"as":[96,206],"way":[98],"recognize":[100],"differential":[102],"significance":[103],"levels":[107],"response.":[109],"Panageas":[110],"colleagues,":[112],"other":[115],"hand,":[116],"trinomial":[119],"model":[120],"direct":[122],"search":[123],"rejection":[127],"region":[128],"separately.":[133],"In":[134,191],"this":[135,192,257],"paper,":[136],"we":[137],"reformat":[138],"their":[139],"hypotheses":[140],"assess":[142],"CR.":[148],"A":[149],"optimum":[152],"phase":[153,183],"trial":[155,185],"developed.":[163],"We":[164],"provide":[165],"guides":[166],"searching":[168],"stopping":[170],"rejecting":[172],"regions":[173],"determining":[176],"sample":[177],"size.":[178],"An":[179],"example":[180],"glioblastomas":[187],"presented.":[190],"trial,":[193],"physicians":[194],"would":[195],"be":[196],"interested":[197],"stable":[200],"disease":[201],"(SD),":[202],"PR,":[203],"an":[207],"indication":[208],"efficacy.":[210],"However,":[211],"because":[212],"rarely":[216],"occur,":[217],"observation":[218],"any":[220],"will":[224],"lean":[225],"towards":[226],"acceptance":[227],"treatment.":[230],"Our":[231],"has":[233],"advantage":[235],"being":[237],"close":[238],"traditional":[241],"Simon":[242],"while":[245],"still":[246],"having":[247],"flexibility":[249],"treat":[251],"(PR":[253],"example)":[258],"differently":[259],"than":[260],"SD.":[261]},"counts_by_year":[{"year":2025,"cited_by_count":1},{"year":2022,"cited_by_count":1},{"year":2021,"cited_by_count":2},{"year":2018,"cited_by_count":1},{"year":2017,"cited_by_count":2},{"year":2016,"cited_by_count":1},{"year":2015,"cited_by_count":3},{"year":2014,"cited_by_count":3},{"year":2013,"cited_by_count":1},{"year":2012,"cited_by_count":3}],"updated_date":"2026-11-01T11:40:01.658920","created_date":"2016-06-24T00:00:00"}