{"id":"https://openalex.org/W2169568401","doi":"https://doi.org/10.1177/1740774512437252","title":"Clinical trial designs for testing biomarker-based personalized therapies","display_name":"Clinical trial designs for testing biomarker-based personalized therapies","publication_year":2012,"publication_date":"2012-03-07","ids":{"openalex":"https://openalex.org/W2169568401","doi":"https://doi.org/10.1177/1740774512437252","mag":"2169568401","pmid":"https://pubmed.ncbi.nlm.nih.gov/22397801","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/4296980"},"language":"en","primary_location":{"id":"doi:10.1177/1740774512437252","doi":"https://doi.org/10.1177/1740774512437252","is_oa":false,"landing_page_url":"https://doi.org/10.1177/1740774512437252","pdf_url":null,"source":{"id":"https://openalex.org/S59378366","display_name":"Clinical Trials","issn_l":"1740-7745","issn":["1740-7745","1740-7753"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","jufo-1","medline","norway-1","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320017","host_organization_name":"SAGE Publishing","host_organization_lineage":["https://openalex.org/P4310320017"],"host_organization_lineage_names":["SAGE Publishing"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Trials","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/4296980","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5109568731","display_name":"Tze Leung Lai","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I97018004","display_name":"Stanford University","ror":"https://ror.org/00f54p054","country_code":"US","type":"education","lineage":["https://openalex.org/I97018004"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Tze Leung Lai","raw_affiliation_strings":["Department of Health Research and Policy, Stanford University, Stanford, CA, USA","Department of Statistics, Stanford University, Stanford, CA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Health Research and Policy, Stanford University, Stanford, CA, USA","institution_ids":["https://openalex.org/I97018004"]},{"raw_affiliation_string":"Department of Statistics, Stanford University, Stanford, CA, USA","institution_ids":["https://openalex.org/I97018004"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5038739415","display_name":"Philip William Lavori","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I97018004","display_name":"Stanford University","ror":"https://ror.org/00f54p054","country_code":"US","type":"education","lineage":["https://openalex.org/I97018004"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Philip W Lavori","raw_affiliation_strings":["Department of Health Research and Policy, Stanford University, Stanford, CA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Health Research and Policy, Stanford University, Stanford, CA, USA","institution_ids":["https://openalex.org/I97018004"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5104050120","display_name":"Mei\u2010Chiung Shih","orcid":"https://orcid.org/0000-0002-3924-5668","observed_orcids":["https://orcid.org/0000-0002-3924-5668"]},"institutions":[{"id":"https://openalex.org/I97018004","display_name":"Stanford University","ror":"https://ror.org/00f54p054","country_code":"US","type":"education","lineage":["https://openalex.org/I97018004"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Mei-Chiung I Shih","raw_affiliation_strings":["Department of Health Research and Policy, Stanford University, Stanford, CA, USA","VA Cooperative Studies Program, Palo Alto, CA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Health Research and Policy, Stanford University, Stanford, CA, USA","institution_ids":["https://openalex.org/I97018004"]},{"raw_affiliation_string":"VA Cooperative Studies Program, Palo Alto, CA, USA","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5019649110","display_name":"Branimir Ivan Sikic","orcid":"https://orcid.org/0000-0001-6814-2070","observed_orcids":["https://orcid.org/0000-0001-6814-2070"]},"institutions":[{"id":"https://openalex.org/I4210137306","display_name":"Stanford Medicine","ror":"https://ror.org/03mtd9a03","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210137306","https://openalex.org/I97018004"]},{"id":"https://openalex.org/I97018004","display_name":"Stanford University","ror":"https://ror.org/00f54p054","country_code":"US","type":"education","lineage":["https://openalex.org/I97018004"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Branimir I Sikic","raw_affiliation_strings":["Department of Medicine, Stanford University, Stanford, CA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medicine, Stanford University, Stanford, CA, USA","institution_ids":["https://openalex.org/I4210137306","https://openalex.org/I97018004"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":{"value":4150,"currency":"USD","value_usd":4150},"apc_paid":null,"fwci":8.2497,"has_fulltext":false,"cited_by_count":48,"citation_normalized_percentile":{"value":0.97923178,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":89,"max":99},"biblio":{"volume":"9","issue":"2","first_page":"141","last_page":"154"},"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/T11798","display_name":"Optimal Experimental Design Methods","score":0.0,"subfield":{"id":"https://openalex.org/subfields/1803","display_name":"Management Science and Operations Research"},"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/T10183","display_name":"Breast Cancer Treatment Studies","score":0.0,"subfield":{"id":"https://openalex.org/subfields/1306","display_name":"Cancer Research"},"field":{"id":"https://openalex.org/fields/13","display_name":"Biochemistry, Genetics and Molecular Biology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/clinical-trial-design","display_name":"clinical trial design","score":0.8949999809265137},{"id":"https://openalex.org/keywords/generalized-likelihood-ratio-test","display_name":"generalized likelihood ratio test","score":0.9049999713897705},{"id":"https://openalex.org/keywords/adaptive-randomization","display_name":"adaptive randomization","score":0.984000027179718},{"id":"https://openalex.org/keywords/futility-stopping","display_name":"futility stopping","score":0.9819999933242798},{"id":"https://openalex.org/keywords/interim-analysis","display_name":"interim analysis","score":0.8299999833106995},{"id":"https://openalex.org/keywords/biomarker-validation","display_name":"biomarker validation","score":0.6589999794960022},{"id":"https://openalex.org/keywords/likelihood-based-inference","display_name":"likelihood-based inference","score":0.3799999952316284}],"concepts":[{"id":"https://openalex.org/C2781197716","wikidata":"https://www.wikidata.org/wiki/Q864574","display_name":"Biomarker","level":2,"score":0.5872405767440796},{"id":"https://openalex.org/C191988596","wikidata":"https://www.wikidata.org/wiki/Q628374","display_name":"Null hypothesis","level":2,"score":0.5500902533531189},{"id":"https://openalex.org/C162376815","wikidata":"https://www.wikidata.org/wiki/Q2158281","display_name":"Frequentist inference","level":4,"score":0.5337992906570435},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.4785233736038208},{"id":"https://openalex.org/C107673813","wikidata":"https://www.wikidata.org/wiki/Q812534","display_name":"Bayesian probability","level":2,"score":0.47034767270088196},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.44863125681877136},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.4241846203804016},{"id":"https://openalex.org/C96608239","wikidata":"https://www.wikidata.org/wiki/Q1199823","display_name":"Statistical power","level":2,"score":0.4240749180316925},{"id":"https://openalex.org/C129848803","wikidata":"https://www.wikidata.org/wiki/Q2564360","display_name":"Sample size determination","level":2,"score":0.42161858081817627},{"id":"https://openalex.org/C32220436","wikidata":"https://www.wikidata.org/wiki/Q2072214","display_name":"Personalized medicine","level":2,"score":0.4199303984642029},{"id":"https://openalex.org/C87007009","wikidata":"https://www.wikidata.org/wiki/Q210832","display_name":"Statistical hypothesis testing","level":2,"score":0.41076481342315674},{"id":"https://openalex.org/C119857082","wikidata":"https://www.wikidata.org/wiki/Q2539","display_name":"Machine learning","level":1,"score":0.3240734934806824},{"id":"https://openalex.org/C154945302","wikidata":"https://www.wikidata.org/wiki/Q11660","display_name":"Artificial intelligence","level":1,"score":0.2767218351364136},{"id":"https://openalex.org/C160234255","wikidata":"https://www.wikidata.org/wiki/Q812535","display_name":"Bayesian inference","level":3,"score":0.275886595249176},{"id":"https://openalex.org/C60644358","wikidata":"https://www.wikidata.org/wiki/Q128570","display_name":"Bioinformatics","level":1,"score":0.2720521092414856},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.2561578154563904},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.1412532925605774},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.1176815927028656},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.09024521708488464},{"id":"https://openalex.org/C55493867","wikidata":"https://www.wikidata.org/wiki/Q7094","display_name":"Biochemistry","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D001499","descriptor_name":"Bayes Theorem","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D004351","descriptor_name":"Drug Resistance","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","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":"D010051","descriptor_name":"Ovarian Neoplasms","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":false},{"descriptor_ui":"D010984","descriptor_name":"Platinum","qualifier_ui":"Q000627","qualifier_name":"therapeutic use","is_major_topic":false},{"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":false},{"descriptor_ui":"D015415","descriptor_name":"Biomarkers","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D016032","descriptor_name":"Randomized Controlled Trials as Topic","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":"D057239","descriptor_name":"Early Termination of Clinical Trials","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D057285","descriptor_name":"Precision Medicine","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":3,"locations":[{"id":"doi:10.1177/1740774512437252","doi":"https://doi.org/10.1177/1740774512437252","is_oa":false,"landing_page_url":"https://doi.org/10.1177/1740774512437252","pdf_url":null,"source":{"id":"https://openalex.org/S59378366","display_name":"Clinical Trials","issn_l":"1740-7745","issn":["1740-7745","1740-7753"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","jufo-1","medline","norway-1","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320017","host_organization_name":"SAGE Publishing","host_organization_lineage":["https://openalex.org/P4310320017"],"host_organization_lineage_names":["SAGE Publishing"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Clinical Trials","raw_type":"journal-article"},{"id":"pmid:22397801","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/22397801","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":"Clinical trials (London, England)","raw_type":"Journal Article"},{"id":"pmh:oai:pubmedcentral.nih.gov:4296980","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/4296980","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":"acceptedVersion","is_accepted":true,"is_published":false,"raw_source_name":"Clin Trials","raw_type":"Text"}],"best_oa_location":{"id":"pmh:oai:pubmedcentral.nih.gov:4296980","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/4296980","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":"acceptedVersion","is_accepted":true,"is_published":false,"raw_source_name":"Clin Trials","raw_type":"Text"},"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.8560000061988831,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[{"id":"https://openalex.org/G2336441735","display_name":"Taxane Resistance in Breast and Ovarian Cancer Cells","funder_award_id":"R01CA114037","funder_id":"https://openalex.org/F4320337351","funder_display_name":"National Cancer Institute"},{"id":"https://openalex.org/G2802423772","display_name":"Spectrum Stanford Center for clinical and Translational Research and Education","funder_award_id":"UL1TR001085","funder_id":"https://openalex.org/F4320332161","funder_display_name":"National Institutes of Health"},{"id":"https://openalex.org/G2828153424","display_name":"Stanford Center for Clinical and Translational Education and Research (SCCTER)UL1","funder_award_id":"UL1RR025744","funder_id":"https://openalex.org/F4320337375","funder_display_name":"National Center for Research Resources"},{"id":"https://openalex.org/G9000859589","display_name":"Stanford Cancer Institute","funder_award_id":"P30CA124435","funder_id":"https://openalex.org/F4320337351","funder_display_name":"National Cancer Institute"}],"funders":[{"id":"https://openalex.org/F4320332161","display_name":"National Institutes of Health","ror":"https://ror.org/01cwqze88"},{"id":"https://openalex.org/F4320337351","display_name":"National Cancer Institute","ror":"https://ror.org/040gcmg81"},{"id":"https://openalex.org/F4320337375","display_name":"National Center for Research Resources","ror":"https://ror.org/04pw6fb54"},{"id":"https://openalex.org/F4320337472","display_name":"National Center for Advancing Translational Sciences","ror":"https://ror.org/04pw6fb54"}],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":40,"referenced_works":["https://openalex.org/W50240922","https://openalex.org/W1568852478","https://openalex.org/W1916389172","https://openalex.org/W1960327677","https://openalex.org/W1969525589","https://openalex.org/W1970308742","https://openalex.org/W1977056311","https://openalex.org/W1986827948","https://openalex.org/W1993827876","https://openalex.org/W2001203833","https://openalex.org/W2005494948","https://openalex.org/W2020287347","https://openalex.org/W2024074772","https://openalex.org/W2029409133","https://openalex.org/W2033369613","https://openalex.org/W2040478536","https://openalex.org/W2041142804","https://openalex.org/W2045092053","https://openalex.org/W2051665639","https://openalex.org/W2069400786","https://openalex.org/W2071150013","https://openalex.org/W2086421866","https://openalex.org/W2093407516","https://openalex.org/W2098184866","https://openalex.org/W2111138915","https://openalex.org/W2116098887","https://openalex.org/W2125071097","https://openalex.org/W2125089526","https://openalex.org/W2130355910","https://openalex.org/W2130862650","https://openalex.org/W2131593373","https://openalex.org/W2137347873","https://openalex.org/W2152773775","https://openalex.org/W2155291829","https://openalex.org/W2161630562","https://openalex.org/W2315952772","https://openalex.org/W2419237537","https://openalex.org/W2493289085","https://openalex.org/W3016972997","https://openalex.org/W4292079585"],"related_works":["https://openalex.org/W2072973192","https://openalex.org/W3105810552","https://openalex.org/W33116237","https://openalex.org/W2155291829","https://openalex.org/W1680941824","https://openalex.org/W2277480360","https://openalex.org/W2125071097","https://openalex.org/W2044854832","https://openalex.org/W2128864973","https://openalex.org/W2076944696"],"abstract_inverted_index":{"BACKGROUND:":[0],"Advances":[1],"in":[2,5,40,79,135,195,213,220,307,332,338],"molecular":[3],"therapeutics":[4],"the":[6,41,67,70,80,96,112,125,136,143,148,162,186,196,199,221,238,241,272,303,308,319,330,333,339],"past":[7],"decade":[8],"have":[9],"opened":[10],"up":[11],"new":[12,52],"possibilities":[13],"for":[14,111,193],"treating":[15],"cancer":[16],"patients":[17,194],"with":[18],"personalized":[19,47,314],"therapies,":[20],"using":[21,322],"biomarkers":[22],"to":[23,30,56,65,75,84,104,156,169,248,274,289,301,328],"determine":[24],"which":[25],"treatments":[26,180],"are":[27,35,283,287,299],"most":[28],"likely":[29],"benefit":[31,232],"them,":[32],"but":[33],"there":[34],"difficulties":[36,304],"and":[37,43,72,83,99,131,161,175,189,210,281,305,310,325,337,344,346],"unresolved":[38],"issues":[39,306],"development":[42,222,309],"validation":[44,311],"of":[45,59,69,95,114,127,145,178,184,201,230,250,271,276,312,321],"biomarker-based":[46,313],"therapies.":[48,315],"We":[49,89,122],"develop":[50],"a":[51,106,158,170,227,264],"clinical":[53,108,235,296],"trial":[54,109,297],"design":[55,110,280],"address":[57,76,302],"some":[58,211],"these":[60],"issues.":[61],"The":[62,216,278,316],"goal":[63],"is":[64,245],"capture":[66],"strengths":[68],"frequentist":[71],"Bayesian":[73],"approaches":[74],"this":[77],"problem":[78,113],"recent":[81,137],"literature":[82],"circumvent":[85],"their":[86],"limitations.":[87],"METHODS:":[88],"use":[90],"generalized":[91],"likelihood":[92,323],"ratio":[93],"tests":[94,282],"intersection":[97,163],"null":[98,102,153,164],"enriched":[100,151],"strategy":[101,152,160,243],"hypotheses":[103],"derive":[105],"novel":[107],"advancing":[115],"promising":[116],"biomarker-guided":[117,242],"strategies":[118],"toward":[119],"eventual":[120],"validation.":[121],"also":[123],"investigate":[124],"usefulness":[126],"adaptive":[128],"randomization":[129],"(AR)":[130],"futility":[132],"stopping":[133],"proposed":[134,159,239,279],"literature.":[138],"RESULTS:":[139],"Simulation":[140],"studies":[141],"demonstrate":[142],"advantages":[144,320],"testing":[146],"both":[147],"narrowly":[149],"focused":[150],"hypothesis":[154,165],"related":[155],"validating":[157],"that":[166,256],"can":[167],"accommodate":[168],"potentially":[171],"successful":[172],"strategy.":[173],"AR":[174],"early":[176],"termination":[177],"ineffective":[179],"offer":[181],"increased":[182],"probability":[183],"receiving":[185],"preferred":[187],"treatment":[188,231],"better":[190],"response":[191,218],"rates":[192],"trial,":[197],"at":[198],"expense":[200],"more":[202],"complicated":[203],"inference":[204,324],"under":[205],"small-to-moderate":[206,291],"total":[207],"sample":[208,292,334],"sizes":[209],"reduction":[212],"power.":[214],"LIMITATIONS:":[215],"binary":[217],"used":[219,288],"phase":[223],"may":[224,257],"not":[225,246,268],"be":[226,258],"reliable":[228],"indicator":[229],"on":[233],"long-term":[234],"outcomes.":[236],"In":[237],"design,":[240],"(BGS)":[244],"compared":[247],"'standard":[249,275],"care',":[251],"such":[252],"as":[253],"physician's":[254],"choice":[255],"informed":[259],"by":[260],"patient":[261],"characteristics.":[262],"Therefore,":[263],"positive":[265],"result":[266],"does":[267],"imply":[269],"superiority":[270],"BGS":[273],"care'.":[277],"valid":[284],"asymptotically.":[285],"Simulations":[286],"examine":[290],"properties.":[293],"CONCLUSION:":[294],"Innovative":[295],"designs":[298],"needed":[300,336],"article":[317],"shows":[318],"interim":[326],"analysis":[327],"meet":[329],"challenges":[331],"size":[335],"constantly":[340],"evolving":[341],"biomarker":[342],"landscape":[343],"genomic":[345],"proteomic":[347],"technologies.":[348]},"counts_by_year":[{"year":2025,"cited_by_count":6},{"year":2024,"cited_by_count":3},{"year":2022,"cited_by_count":1},{"year":2020,"cited_by_count":2},{"year":2019,"cited_by_count":3},{"year":2018,"cited_by_count":3},{"year":2017,"cited_by_count":1},{"year":2016,"cited_by_count":2},{"year":2015,"cited_by_count":5},{"year":2014,"cited_by_count":4},{"year":2013,"cited_by_count":10},{"year":2012,"cited_by_count":8}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2016-06-24T00:00:00"}