{"id":"https://openalex.org/W4390528893","doi":"https://doi.org/10.48550/arxiv.2401.00540","title":"Study Duration Prediction for Clinical Trials with Time-to-Event Endpoints Using Mixture Distributions Accounting for Heterogeneous Population","display_name":"Study Duration Prediction for Clinical Trials with Time-to-Event Endpoints Using Mixture Distributions Accounting for Heterogeneous Population","publication_year":2023,"publication_date":"2023-12-31","ids":{"openalex":"https://openalex.org/W4390528893","doi":"https://doi.org/10.48550/arxiv.2401.00540"},"language":"en","primary_location":{"id":"pmh:oai:arXiv.org:2401.00540","doi":null,"is_oa":true,"landing_page_url":"http://arxiv.org/abs/2401.00540","pdf_url":"https://arxiv.org/pdf/2401.00540","source":{"id":"https://openalex.org/S4306400194","display_name":"arXiv (Cornell University)","issn_l":"2331-8422","issn":["2331-8422"],"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I205783295","host_organization_name":"Cornell University","host_organization_lineage":["https://openalex.org/I205783295"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"text"},"volume":null,"type":"preprint","indexed_in":["arxiv","datacite"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://arxiv.org/pdf/2401.00540","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":null,"display_name":"Zhang, Hong","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I180857899","display_name":"Pfizer (United States)","ror":"https://ror.org/01xdqrp08","country_code":"US","type":"company","lineage":["https://openalex.org/I180857899"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Zhang, Hong","raw_affiliation_strings":["Global Biometrics and Data Management , Pfizer Inc. , New York , New York , USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Global Biometrics and Data Management , Pfizer Inc. , New York , New York , USA","institution_ids":["https://openalex.org/I180857899"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5002706809","display_name":"Jie Pu","orcid":"https://orcid.org/0009-0006-9007-5955","observed_orcids":["https://orcid.org/0009-0006-9007-5955"]},"institutions":[{"id":"https://openalex.org/I180857899","display_name":"Pfizer (United States)","ror":"https://ror.org/01xdqrp08","country_code":"US","type":"company","lineage":["https://openalex.org/I180857899"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Pu, Jie","raw_affiliation_strings":["Global Biometrics and Data Management , Pfizer Inc. , New York , New York , USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Global Biometrics and Data Management , Pfizer Inc. , New York , New York , USA","institution_ids":["https://openalex.org/I180857899"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5002187013","display_name":"Shibing Deng","orcid":"https://orcid.org/0000-0002-2867-263X","observed_orcids":["https://orcid.org/0000-0002-2867-263X"]},"institutions":[{"id":"https://openalex.org/I180857899","display_name":"Pfizer (United States)","ror":"https://ror.org/01xdqrp08","country_code":"US","type":"company","lineage":["https://openalex.org/I180857899"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Deng, Shibing","raw_affiliation_strings":["Global Biometrics and Data Management , Pfizer Inc. , New York , New York , USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Global Biometrics and Data Management , Pfizer Inc. , New York , New York , USA","institution_ids":["https://openalex.org/I180857899"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5016431348","display_name":"Satrajit Roychoudhury","orcid":"https://orcid.org/0000-0003-4001-3036","observed_orcids":["https://orcid.org/0000-0003-4001-3036"]},"institutions":[{"id":"https://openalex.org/I180857899","display_name":"Pfizer (United States)","ror":"https://ror.org/01xdqrp08","country_code":"US","type":"company","lineage":["https://openalex.org/I180857899"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Roychoudhury, Satrajit","raw_affiliation_strings":["Global Biometrics and Data Management , Pfizer Inc. , New York , New York , USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Global Biometrics and Data Management , Pfizer Inc. , New York , New York , USA","institution_ids":["https://openalex.org/I180857899"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5004584518","display_name":"Haitao Chu","orcid":"https://orcid.org/0000-0003-0932-598X","observed_orcids":["https://orcid.org/0000-0003-0932-598X"]},"institutions":[{"id":"https://openalex.org/I130238516","display_name":"University of Minnesota","ror":"https://ror.org/017zqws13","country_code":"US","type":"education","lineage":["https://openalex.org/I130238516"]},{"id":"https://openalex.org/I180857899","display_name":"Pfizer (United States)","ror":"https://ror.org/01xdqrp08","country_code":"US","type":"company","lineage":["https://openalex.org/I180857899"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Chu, Haitao","raw_affiliation_strings":["Division of Biostatistics , School of Public Health , University of Minnesota , Minneapolis , Minnesota , USA","Global Biometrics and Data Management , Pfizer Inc. , New York , New York , USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Division of Biostatistics , School of Public Health , University of Minnesota , Minneapolis , Minnesota , USA","institution_ids":["https://openalex.org/I130238516"]},{"raw_affiliation_string":"Global Biometrics and Data Management , Pfizer Inc. , New York , New York , USA","institution_ids":["https://openalex.org/I180857899"]}]},{"author_position":"last","author":{"id":null,"display_name":"Robinson, Douglas","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I180857899","display_name":"Pfizer (United States)","ror":"https://ror.org/01xdqrp08","country_code":"US","type":"company","lineage":["https://openalex.org/I180857899"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Robinson, Douglas","raw_affiliation_strings":["Global Biometrics and Data Management , Pfizer Inc. , New York , New York , USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Global Biometrics and Data Management , Pfizer Inc. , New York , New York , USA","institution_ids":["https://openalex.org/I180857899"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.9990000128746033,"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":0.9990000128746033,"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":0.00019999999494757503,"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/T14374","display_name":"Statistical Methods in Epidemiology","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"}}],"keywords":[{"id":"https://openalex.org/keywords/time-to-event-endpoints","display_name":"time-to-event outcomes","score":0.8600000143051147},{"id":"https://openalex.org/keywords/mixture-distributions","display_name":"mixture distributions","score":0.8830000162124634},{"id":"https://openalex.org/keywords/heterogeneous-populations","display_name":"heterogeneous populations","score":0.6909999847412109},{"id":"https://openalex.org/keywords/precision-medicine","display_name":"precision medicine","score":0.6240000128746033},{"id":"https://openalex.org/keywords/enrollment-rates","display_name":"enrollment rates","score":0.8090000152587891},{"id":"https://openalex.org/keywords/biomarker-prevalence","display_name":"biomarker prevalence","score":0.8769999742507935},{"id":"https://openalex.org/keywords/median-survival","display_name":"median survival time","score":0.8320000171661377}],"concepts":[{"id":"https://openalex.org/C2781197716","wikidata":"https://www.wikidata.org/wiki/Q864574","display_name":"Biomarker","level":2,"score":0.772813081741333},{"id":"https://openalex.org/C2908647359","wikidata":"https://www.wikidata.org/wiki/Q2625603","display_name":"Population","level":2,"score":0.5904077291488647},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.5591623783111572},{"id":"https://openalex.org/C112758219","wikidata":"https://www.wikidata.org/wiki/Q16038819","display_name":"Duration (music)","level":2,"score":0.5100210309028625},{"id":"https://openalex.org/C148482608","wikidata":"https://www.wikidata.org/wiki/Q17007018","display_name":"Clinical study design","level":3,"score":0.4516075551509857},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.40818989276885986},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.3797927498817444},{"id":"https://openalex.org/C143998085","wikidata":"https://www.wikidata.org/wiki/Q162555","display_name":"Oncology","level":1,"score":0.32990026473999023},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.3202379047870636},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.29422450065612793},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.1260780692100525},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.0795033872127533},{"id":"https://openalex.org/C124952713","wikidata":"https://www.wikidata.org/wiki/Q8242","display_name":"Literature","level":1,"score":0.0},{"id":"https://openalex.org/C142362112","wikidata":"https://www.wikidata.org/wiki/Q735","display_name":"Art","level":0,"score":0.0},{"id":"https://openalex.org/C55493867","wikidata":"https://www.wikidata.org/wiki/Q7094","display_name":"Biochemistry","level":1,"score":0.0},{"id":"https://openalex.org/C99454951","wikidata":"https://www.wikidata.org/wiki/Q932068","display_name":"Environmental health","level":1,"score":0.0}],"mesh":[],"locations_count":2,"locations":[{"id":"pmh:oai:arXiv.org:2401.00540","doi":null,"is_oa":true,"landing_page_url":"http://arxiv.org/abs/2401.00540","pdf_url":"https://arxiv.org/pdf/2401.00540","source":{"id":"https://openalex.org/S4306400194","display_name":"arXiv (Cornell University)","issn_l":"2331-8422","issn":["2331-8422"],"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I205783295","host_organization_name":"Cornell University","host_organization_lineage":["https://openalex.org/I205783295"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"text"},{"id":"doi:10.48550/arxiv.2401.00540","doi":"https://doi.org/10.48550/arxiv.2401.00540","is_oa":true,"landing_page_url":"https://doi.org/10.48550/arxiv.2401.00540","pdf_url":null,"source":{"id":"https://openalex.org/S4306400194","display_name":"arXiv (Cornell University)","issn_l":"2331-8422","issn":["2331-8422"],"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I205783295","host_organization_name":"Cornell University","host_organization_lineage":["https://openalex.org/I205783295"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":null,"is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"Preprint"}],"best_oa_location":{"id":"pmh:oai:arXiv.org:2401.00540","doi":null,"is_oa":true,"landing_page_url":"http://arxiv.org/abs/2401.00540","pdf_url":"https://arxiv.org/pdf/2401.00540","source":{"id":"https://openalex.org/S4306400194","display_name":"arXiv (Cornell University)","issn_l":"2331-8422","issn":["2331-8422"],"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I205783295","host_organization_name":"Cornell University","host_organization_lineage":["https://openalex.org/I205783295"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"text"},"sustainable_development_goals":[{"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3","score":0.7246000170707703}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4390528893.pdf","grobid_xml":"https://content.openalex.org/works/W4390528893.grobid-xml"},"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W4409602326","https://openalex.org/W2921364429","https://openalex.org/W1998710012","https://openalex.org/W4409090430","https://openalex.org/W3087427476","https://openalex.org/W1984919683","https://openalex.org/W2152150943","https://openalex.org/W2783858548","https://openalex.org/W6963065507","https://openalex.org/W4280573579"],"abstract_inverted_index":{"In":[0],"the":[1,41,54,64,67,76,127,133,141,171,177,188],"era":[2],"of":[3,28,129,135,161],"precision":[4],"medicine,":[5],"more":[6,8],"and":[7,24,46,132,138,155,174,191],"clinical":[9,51],"trials":[10,52,165],"are":[11,19,123,158,166],"now":[12],"driven":[13],"or":[14,34,60],"guided":[15],"by":[16,56],"biomarkers,":[17],"which":[18,81],"patient":[20],"characteristics":[21,137],"objectively":[22],"measured":[23],"evaluated":[25],"as":[26],"indicators":[27],"normal":[29],"biological":[30],"processes,":[31,33],"pathogenic":[32],"pharmacologic":[35],"responses":[36],"to":[37,44,75,90,93,99,125,168,175,186],"therapeutic":[38],"interventions.":[39],"With":[40],"overarching":[42],"objective":[43],"optimize":[45],"personalize":[47],"disease":[48,139],"management,":[49],"biomarker-guided":[50,106],"increase":[53],"efficiency":[55,68],"appropriately":[57],"utilizing":[58],"prognostic":[59],"predictive":[61],"biomarkers":[62],"in":[63,80],"design.":[65],"However,":[66],"gain":[69],"is":[70,86,184,192],"often":[71],"not":[72],"quantitatively":[73],"compared":[74],"traditional":[77],"all-comers":[78],"design,":[79],"a":[82,100,111],"faster":[83],"enrollment":[84,151],"rate":[85],"expected":[87],"(e.g.":[88],"due":[89],"no":[91],"restriction":[92],"biomarker":[94,136,153],"positive":[95],"patients)":[96],"potentially":[97],"leading":[98],"shorter":[101],"duration.":[102,143],"To":[103],"accurately":[104],"predict":[105],"trial":[107],"duration,":[108],"we":[109],"propose":[110],"general":[112],"framework":[113],"using":[114],"mixture":[115],"distributions":[116],"accounting":[117],"for":[118],"heterogeneous":[119,130],"population.":[120],"Extensive":[121],"simulations":[122],"performed":[124],"evaluate":[126],"impact":[128],"population":[131],"dynamics":[134],"on":[140,195],"study":[142],"Several":[144],"influential":[145],"parameters":[146],"including":[147],"median":[148],"survival":[149],"time,":[150],"rate,":[152],"prevalence":[154],"effect":[156],"size":[157],"identitied.":[159],"Re-assessments":[160],"two":[162],"publicly":[163,193],"available":[164,194],"conducted":[167],"empirically":[169],"validate":[170],"prediction":[172],"accuracy":[173],"demonstrate":[176],"practical":[178],"utility.":[179],"The":[180],"R":[181],"package":[182],"\\emph{detest}":[183],"developed":[185],"implement":[187],"proposed":[189],"method":[190],"CRAN.":[196]},"counts_by_year":[],"updated_date":"2026-10-14T16:39:01.820549","created_date":"2024-01-03T00:00:00"}