{"id":"https://openalex.org/W4206117788","doi":"https://doi.org/10.1109/bigdata52589.2021.9671293","title":"Real World Data for Clinical Trials Designs using Machine Learning","display_name":"Real World Data for Clinical Trials Designs using Machine Learning","publication_year":2021,"publication_date":"2021-12-15","ids":{"openalex":"https://openalex.org/W4206117788","doi":"https://doi.org/10.1109/bigdata52589.2021.9671293"},"language":"en","primary_location":{"id":"doi:10.1109/bigdata52589.2021.9671293","is_oa":false,"landing_page_url":"https://doi.org/10.1109/bigdata52589.2021.9671293","pdf_url":null,"source":{"id":"https://openalex.org/S4363607718","display_name":"2021 IEEE International Conference on Big Data (Big Data)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"conference"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"2021 IEEE International Conference on Big Data (Big Data)","raw_type":"proceedings-article"},"type":"article","indexed_in":["crossref"],"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/A5064886715","display_name":"T R Krishna Prasad","orcid":null},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"Thejas Prasad","raw_affiliation_strings":["Pattern Sciences Incorporated, Austin, USA"],"affiliations":[{"raw_affiliation_string":"Pattern Sciences Incorporated, Austin, USA","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5066320223","display_name":"Shakeel Rashed","orcid":null},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Shakeel Rashed","raw_affiliation_strings":["Pattern Sciences Incorporated, Austin, USA"],"affiliations":[{"raw_affiliation_string":"Pattern Sciences Incorporated, Austin, USA","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":2,"corresponding_author_ids":["https://openalex.org/A5064886715"],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.4222,"has_fulltext":false,"cited_by_count":1,"citation_normalized_percentile":{"value":0.5786802,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":89,"max":94},"biblio":{"volume":"12","issue":null,"first_page":"5991","last_page":"5993"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.9970999956130981,"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":0.9970999956130981,"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/T10845","display_name":"Advanced Causal Inference Techniques","score":0.9940999746322632,"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/T12255","display_name":"Biosimilars and Bioanalytical Methods","score":0.9591000080108643,"subfield":{"id":"https://openalex.org/subfields/2403","display_name":"Immunology"},"field":{"id":"https://openalex.org/fields/24","display_name":"Immunology and Microbiology"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/observational-study","display_name":"Observational study","score":0.8736089468002319},{"id":"https://openalex.org/keywords/randomization","display_name":"Randomization","score":0.6595271825790405},{"id":"https://openalex.org/keywords/randomized-controlled-trial","display_name":"Randomized controlled trial","score":0.6269496083259583},{"id":"https://openalex.org/keywords/clinical-trial","display_name":"Clinical trial","score":0.6093538999557495},{"id":"https://openalex.org/keywords/medicine","display_name":"Medicine","score":0.4642968773841858},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.4438287615776062},{"id":"https://openalex.org/keywords/drug","display_name":"Drug","score":0.44094574451446533},{"id":"https://openalex.org/keywords/medical-physics","display_name":"Medical physics","score":0.42615973949432373},{"id":"https://openalex.org/keywords/pharmacology","display_name":"Pharmacology","score":0.1590982973575592},{"id":"https://openalex.org/keywords/surgery","display_name":"Surgery","score":0.10594552755355835},{"id":"https://openalex.org/keywords/internal-medicine","display_name":"Internal medicine","score":0.09466499090194702}],"concepts":[{"id":"https://openalex.org/C23131810","wikidata":"https://www.wikidata.org/wiki/Q818574","display_name":"Observational study","level":2,"score":0.8736089468002319},{"id":"https://openalex.org/C204243189","wikidata":"https://www.wikidata.org/wiki/Q1363085","display_name":"Randomization","level":3,"score":0.6595271825790405},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.6269496083259583},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.6093538999557495},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.4642968773841858},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.4438287615776062},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.44094574451446533},{"id":"https://openalex.org/C19527891","wikidata":"https://www.wikidata.org/wiki/Q1120908","display_name":"Medical physics","level":1,"score":0.42615973949432373},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.1590982973575592},{"id":"https://openalex.org/C141071460","wikidata":"https://www.wikidata.org/wiki/Q40821","display_name":"Surgery","level":1,"score":0.10594552755355835},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.09466499090194702}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1109/bigdata52589.2021.9671293","is_oa":false,"landing_page_url":"https://doi.org/10.1109/bigdata52589.2021.9671293","pdf_url":null,"source":{"id":"https://openalex.org/S4363607718","display_name":"2021 IEEE International Conference on Big Data (Big Data)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"conference"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"2021 IEEE International Conference on Big Data (Big Data)","raw_type":"proceedings-article"}],"best_oa_location":null,"sustainable_development_goals":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":4,"referenced_works":["https://openalex.org/W1523985187","https://openalex.org/W2101234009","https://openalex.org/W3150893739","https://openalex.org/W6675354045"],"related_works":["https://openalex.org/W4381328000","https://openalex.org/W2109147503","https://openalex.org/W2322581019","https://openalex.org/W2103779230","https://openalex.org/W2911339178","https://openalex.org/W334096847","https://openalex.org/W3141050733","https://openalex.org/W2030936866","https://openalex.org/W1533309927","https://openalex.org/W1986983868"],"abstract_inverted_index":{"A":[0,34],"common":[1],"problem":[2],"in":[3,11,56],"the":[4,12,23,57,97,105],"pharmaceutical":[5],"industry":[6],"is":[7,43,68,95,112],"tracking":[8],"drug":[9,35,62,73],"usage":[10],"post":[13],"approval":[14],"phase.":[15],"This":[16,111],"paper":[17],"proposes":[18],"a":[19,113,123,147],"solution":[20],"to":[21,45,47,64,70,80,88,104,139],"analyzing":[22],"efficacy":[24,50],"of":[25,90,108,143,150],"\"off":[26],"label\"":[27],"antiretroviral":[28],"therapies":[29],"(ART)":[30],"using":[31],"observational":[32,109],"data.":[33,110],"which":[36,121],"been":[37],"approved":[38],"by":[39],"FDA":[40],"for":[41,74,141],"men,":[42],"prescribed":[44,63],"women":[46,52,65],"evaluate":[48],"its":[49],"although":[51],"were":[53],"not":[54,100],"included":[55],"initial":[58],"clinical":[59],"trials.":[60],"The":[61,76,92],"off":[66],"label":[67],"compared":[69],"an":[71],"antecedent":[72],"efficacy.":[75],"study":[77],"gives":[78],"rise":[79],"challenges":[81],"with":[82],"RWD":[83],"comprising":[84],"both":[85],"arms":[86],"subject":[87],"lack":[89,142],"randomization.":[91],"principal":[93],"issue":[94],"that":[96,134],"groups":[98],"may":[99],"be":[101],"comparable":[102],"due":[103],"inherent":[106],"nature":[107],"significant":[114],"departure":[115],"from":[116],"randomized":[117],"controlled":[118],"trials":[119],"(RCT)":[120],"are":[122],"time":[124],"tested":[125],"gold":[126],"standard.":[127],"In":[128],"this":[129],"setting,":[130],"we":[131],"propose":[132],"approaches":[133],"use":[135],"patient-level":[136],"pre-treatment":[137],"covariates":[138],"adjust":[140],"randomization":[144],"and":[145],"facilitate":[146],"viable":[148],"comparison":[149],"treatment":[151],"outcomes.":[152]},"counts_by_year":[{"year":2023,"cited_by_count":1}],"updated_date":"2025-11-06T03:46:38.306776","created_date":"2025-10-10T00:00:00"}
