{"id":"https://openalex.org/W2024344381","doi":"https://doi.org/10.1002/(sici)1097-0258(19980115)17:1<75::aid-sim731>3.0.co;2-n","title":"The use of simulation and bootstrap in information-based group sequential studies","display_name":"The use of simulation and bootstrap in information-based group sequential studies","publication_year":1998,"publication_date":"1998-01-15","ids":{"openalex":"https://openalex.org/W2024344381","doi":"https://doi.org/10.1002/(sici)1097-0258(19980115)17:1<75::aid-sim731>3.0.co;2-n","mag":"2024344381","pmid":"https://pubmed.ncbi.nlm.nih.gov/9463851"},"language":"en","primary_location":{"id":"doi:10.1002/(sici)1097-0258(19980115)17:1<75::aid-sim731>3.0.co;2-n","doi":"https://doi.org/10.1002/(sici)1097-0258(19980115)17:1<75::aid-sim731>3.0.co;2-n","is_oa":false,"landing_page_url":"https://doi.org/10.1002/(sici)1097-0258(19980115)17:1<75::aid-sim731>3.0.co;2-n","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":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5028193922","display_name":"Daniel O. Scharfstein","orcid":"https://orcid.org/0000-0001-7482-9653","observed_orcids":["https://orcid.org/0000-0001-7482-9653"]},"institutions":[{"id":"https://openalex.org/I145311948","display_name":"Johns Hopkins University","ror":"https://ror.org/00za53h95","country_code":"US","type":"education","lineage":["https://openalex.org/I145311948"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Daniel O. Scharfstein","raw_affiliation_strings":["Department of Biostatistics, Johns Hopkins School of Public Health, Baltimore, MD 21205-2179, USA","Department of Biostatistics, Johns Hopkins School of Public Health, 615 N. Wolfe Street, Baltimore, MD 21205-2179, U.S.A"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Biostatistics, Johns Hopkins School of Public Health, Baltimore, MD 21205-2179, USA","institution_ids":["https://openalex.org/I145311948"]},{"raw_affiliation_string":"Department of Biostatistics, Johns Hopkins School of Public Health, 615 N. Wolfe Street, Baltimore, MD 21205-2179, U.S.A","institution_ids":["https://openalex.org/I145311948"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5057991167","display_name":"Anastasios A. Tsiatis","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I137902535","display_name":"North Carolina State University","ror":"https://ror.org/04tj63d06","country_code":"US","type":"education","lineage":["https://openalex.org/I137902535"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Anastasios A. Tsiatis","raw_affiliation_strings":["Department of Statistics, North Carolina State University, P.O. Box 8203, Raleigh, NC 27695-8203, U.S.A"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Statistics, North Carolina State University, P.O. Box 8203, Raleigh, NC 27695-8203, U.S.A","institution_ids":["https://openalex.org/I137902535"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":["https://openalex.org/A5028193922"],"corresponding_institution_ids":["https://openalex.org/I145311948"],"apc_list":{"value":5450,"currency":"USD","value_usd":5450},"apc_paid":null,"fwci":2.3468,"has_fulltext":false,"cited_by_count":30,"citation_normalized_percentile":{"value":0.88727225,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":89,"max":99},"biblio":{"volume":"17","issue":"1","first_page":"75","last_page":"87"},"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/T10243","display_name":"Statistical Methods and Bayesian Inference","score":9.999999747378752e-05,"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/T11195","display_name":"Simulation Techniques and Applications","score":9.999999747378752e-05,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/group-sequential-trials","display_name":"group sequential trials","score":0.7179999947547913},{"id":"https://openalex.org/keywords/bootstrap-method","display_name":"bootstrapping","score":0.6190000176429749},{"id":"https://openalex.org/keywords/simulation","display_name":"simulation","score":0.8289999961853027},{"id":"https://openalex.org/keywords/interim-analysis","display_name":"interim analysis","score":0.871999979019165},{"id":"https://openalex.org/keywords/prediction-intervals","display_name":"prediction intervals","score":0.7680000066757202},{"id":"https://openalex.org/keywords/nuisance-parameters","display_name":"nuisance parameters","score":0.6840000152587891}],"concepts":[{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.7488980293273926},{"id":"https://openalex.org/C2776957806","wikidata":"https://www.wikidata.org/wiki/Q4895105","display_name":"Interim","level":2,"score":0.6977724432945251},{"id":"https://openalex.org/C61943457","wikidata":"https://www.wikidata.org/wiki/Q6046661","display_name":"Interim analysis","level":3,"score":0.584738552570343},{"id":"https://openalex.org/C40696583","wikidata":"https://www.wikidata.org/wiki/Q989120","display_name":"Type I and type II errors","level":2,"score":0.5603736639022827},{"id":"https://openalex.org/C2780385302","wikidata":"https://www.wikidata.org/wiki/Q367158","display_name":"Protocol (science)","level":3,"score":0.5433573722839355},{"id":"https://openalex.org/C124101348","wikidata":"https://www.wikidata.org/wiki/Q172491","display_name":"Data mining","level":1,"score":0.5359457731246948},{"id":"https://openalex.org/C80478641","wikidata":"https://www.wikidata.org/wiki/Q195771","display_name":"Sequential analysis","level":2,"score":0.4992954730987549},{"id":"https://openalex.org/C2781311116","wikidata":"https://www.wikidata.org/wiki/Q83306","display_name":"Group (periodic table)","level":2,"score":0.440968781709671},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.24445250630378723},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.20924237370491028},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.10142874717712402},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.07895901799201965},{"id":"https://openalex.org/C166957645","wikidata":"https://www.wikidata.org/wiki/Q23498","display_name":"Archaeology","level":1,"score":0.0},{"id":"https://openalex.org/C178790620","wikidata":"https://www.wikidata.org/wiki/Q11351","display_name":"Organic chemistry","level":1,"score":0.0},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.0},{"id":"https://openalex.org/C185592680","wikidata":"https://www.wikidata.org/wiki/Q2329","display_name":"Chemistry","level":0,"score":0.0},{"id":"https://openalex.org/C95457728","wikidata":"https://www.wikidata.org/wiki/Q309","display_name":"History","level":0,"score":0.0},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.0}],"mesh":[{"descriptor_ui":"D000328","descriptor_name":"Adult","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":"D003198","descriptor_name":"Computer Simulation","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005544","descriptor_name":"Forecasting","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":"D008137","descriptor_name":"Longitudinal Studies","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D011020","descriptor_name":"Pneumonia, Pneumocystis","qualifier_ui":"Q000517","qualifier_name":"prevention & control","is_major_topic":false},{"descriptor_ui":"D012107","descriptor_name":"Research Design","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D017088","descriptor_name":"AIDS-Related Opportunistic Infections","qualifier_ui":"Q000517","qualifier_name":"prevention & control","is_major_topic":false},{"descriptor_ui":"D018890","descriptor_name":"Chemoprevention","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":3,"locations":[{"id":"doi:10.1002/(sici)1097-0258(19980115)17:1<75::aid-sim731>3.0.co;2-n","doi":"https://doi.org/10.1002/(sici)1097-0258(19980115)17:1<75::aid-sim731>3.0.co;2-n","is_oa":false,"landing_page_url":"https://doi.org/10.1002/(sici)1097-0258(19980115)17:1<75::aid-sim731>3.0.co;2-n","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":"doi:10.1002/(sici)1097-0258(19980115)17:1<75::aid-sim731>3.3.co;2-e","doi":"https://doi.org/10.1002/(sici)1097-0258(19980115)17:1<75::aid-sim731>3.3.co;2-e","is_oa":false,"landing_page_url":"https://doi.org/10.1002/(sici)1097-0258(19980115)17:1<75::aid-sim731>3.3.co;2-e","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:9463851","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/9463851","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":[],"study_designs":[],"awards":[{"id":"https://openalex.org/G2286198040","display_name":"STATISTICAL METHODS FOR AIDS CLINICAL TRIALS","funder_award_id":"R01AI031789","funder_id":"https://openalex.org/F4320337355","funder_display_name":"National Institute of Allergy and Infectious Diseases"},{"id":"https://openalex.org/G8603079928","display_name":"Statistical Analysis of Complex Data in Cancer","funder_award_id":"R01CA051962","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/F4320337355","display_name":"National Institute of Allergy and Infectious Diseases","ror":"https://ror.org/043z4tv69"}],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2131571090","https://openalex.org/W7097763553","https://openalex.org/W7100032698","https://openalex.org/W2163311758","https://openalex.org/W2529646581","https://openalex.org/W2132770882","https://openalex.org/W4394571757","https://openalex.org/W4391883389","https://openalex.org/W1972431250","https://openalex.org/W7097926359"],"abstract_inverted_index":{"In":[0],"this":[1,47,96],"paper,":[2],"we":[3,59],"present":[4],"an":[5],"information-based":[6],"design":[7,44],"and":[8,77],"monitoring":[9,92],"procedure":[10],"which":[11,84],"applies":[12],"to":[13,41,74,98,112,115],"any":[14,19],"type":[15,20],"of":[16,21,31,46,56,103,123],"model":[17],"for":[18,80],"group":[22],"sequential":[23],"study":[24,86],"provided":[25],"there":[26],"is":[27,106],"a":[28,61,101],"unique":[29],"parameter":[30],"interest":[32],"one":[33],"can":[34,94],"estimate":[35],"efficiently.":[36],"Simulation":[37],"techniques":[38,125],"are":[39],"described":[40],"handle":[42],"the":[43,66,70,81,85,104],"phase":[45],"procedure.":[48],"Since":[49],"designs":[50],"depend":[51],"on":[52],"potentially":[53],"unreliable":[54],"guesses":[55],"nuisance":[57],"parameters,":[58],"propose":[60],"bootstrap":[62],"method":[63],"that":[64],"uses":[65],"information":[67,97],"available":[68],"at":[69,83],"interim":[71],"analysis":[72],"times":[73],"generate":[75],"projections":[76],"prediction":[78],"intervals":[79],"time":[82],"will":[87],"be":[88],"fully":[89],"powered.":[90],"A":[91],"board":[93],"use":[95,113],"decide":[99],"whether":[100],"redesign":[102,116],"trial":[105],"warranted.":[107],"We":[108,120],"also":[109],"show":[110],"how":[111],"simulation":[114],"studies":[117],"in":[118],"progress.":[119],"illustrate":[121],"all":[122],"these":[124],"with":[126],"data":[127],"from":[128],"AIDS":[129],"Clinical":[130],"Trial":[131],"Group":[132],"Protocol":[133],"021.":[134]},"counts_by_year":[{"year":2018,"cited_by_count":3},{"year":2015,"cited_by_count":1},{"year":2012,"cited_by_count":8}],"updated_date":"2026-11-01T11:40:01.658920","created_date":"2016-06-24T00:00:00"}
