{"id":"https://openalex.org/W4410325596","doi":"https://doi.org/10.7759/cureus.84007","title":"In Silico Research Is Rewriting the Rules of Drug Development: Is It the End of Human Trials?","display_name":"In Silico Research Is Rewriting the Rules of Drug Development: Is It the End of Human Trials?","publication_year":2025,"publication_date":"2025-05-13","ids":{"openalex":"https://openalex.org/W4410325596","doi":"https://doi.org/10.7759/cureus.84007","pmid":"https://pubmed.ncbi.nlm.nih.gov/40364863","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/12070237"},"language":"en","primary_location":{"id":"doi:10.7759/cureus.84007","doi":"https://doi.org/10.7759/cureus.84007","is_oa":true,"landing_page_url":"https://doi.org/10.7759/cureus.84007","pdf_url":"https://assets.cureus.com/uploads/editorial/pdf/366260/20250513-657042-ma3ego.pdf","source":{"id":"https://openalex.org/S2738950867","display_name":"Cureus","issn_l":"2168-8184","issn":["2168-8184"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","poland-20","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310316779","host_organization_name":"Cureus, Inc.","host_organization_lineage":["https://openalex.org/P4310316779"],"host_organization_lineage_names":["Cureus, Inc."],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Cureus","raw_type":"journal-article"},"volume":null,"type":"editorial","is_traditional":true,"indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"diamond","oa_url":"https://assets.cureus.com/uploads/editorial/pdf/366260/20250513-657042-ma3ego.pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5079941092","display_name":"Shaheen Emmanuel Lakhan","orcid":"https://orcid.org/0000-0002-2994-3630","observed_orcids":["https://orcid.org/0000-0002-2994-3630"]},"institutions":[{"id":"https://openalex.org/I4210115604","display_name":"Global Neuroscience Initiative Foundation","ror":"https://ror.org/02g726t95","country_code":"US","type":"nonprofit","lineage":["https://openalex.org/I4210115604"]},{"id":"https://openalex.org/I4405268034","display_name":"Click Therapeutics, Inc. (United States)","ror":"https://ror.org/05frdy048","country_code":"US","type":"company","lineage":["https://openalex.org/I4405268034"]},{"id":"https://openalex.org/I4584351","display_name":"A.T. Still University","ror":"https://ror.org/05hr6q169","country_code":"US","type":"education","lineage":["https://openalex.org/I4584351"]},{"id":"https://openalex.org/I6332465","display_name":"Morehouse School of Medicine","ror":"https://ror.org/01pbhra64","country_code":"US","type":"education","lineage":["https://openalex.org/I6332465"]},{"id":"https://openalex.org/I93393672","display_name":"Western University of Health Sciences","ror":"https://ror.org/05167c961","country_code":"US","type":"education","lineage":["https://openalex.org/I93393672"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Shaheen E Lakhan","raw_affiliation_strings":["Department of Bioscience, Global Neuroscience Initiative Foundation, Miami, USA","Department of Neurology, A.T. Still University School of Osteopathic Medicine in Arizona, Mesa, USA","Department of Neurology, Morehouse School of Medicine, Atlanta, USA","Department of Neurology, Western University of Health Sciences, Pomona, USA","Medical Office, Click Therapeutics, Inc., New York, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Bioscience, Global Neuroscience Initiative Foundation, Miami, USA","institution_ids":["https://openalex.org/I4210115604"]},{"raw_affiliation_string":"Department of Neurology, A.T. Still University School of Osteopathic Medicine in Arizona, Mesa, USA","institution_ids":["https://openalex.org/I4584351"]},{"raw_affiliation_string":"Department of Neurology, Morehouse School of Medicine, Atlanta, USA","institution_ids":["https://openalex.org/I6332465"]},{"raw_affiliation_string":"Department of Neurology, Western University of Health Sciences, Pomona, USA","institution_ids":["https://openalex.org/I93393672"]},{"raw_affiliation_string":"Medical Office, Click Therapeutics, Inc., New York, USA","institution_ids":["https://openalex.org/I4405268034"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":5,"corresponding_author_ids":["https://openalex.org/A5079941092"],"corresponding_institution_ids":["https://openalex.org/I4210115604","https://openalex.org/I4405268034","https://openalex.org/I4584351","https://openalex.org/I6332465","https://openalex.org/I93393672"],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":true,"cited_by_count":6,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"17","issue":"5","first_page":"e84007","last_page":"e84007"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10211","display_name":"Computational Drug Discovery Methods","score":0.7397000193595886,"subfield":{"id":"https://openalex.org/subfields/3002","display_name":"Drug Discovery"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T10211","display_name":"Computational Drug Discovery Methods","score":0.7397000193595886,"subfield":{"id":"https://openalex.org/subfields/3002","display_name":"Drug Discovery"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T12281","display_name":"Animal testing and alternatives","score":0.1949000060558319,"subfield":{"id":"https://openalex.org/subfields/3404","display_name":"Small Animals"},"field":{"id":"https://openalex.org/fields/34","display_name":"Veterinary"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11636","display_name":"Artificial Intelligence in Healthcare and Education","score":0.029400000348687172,"subfield":{"id":"https://openalex.org/subfields/2718","display_name":"Health Informatics"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/digital-twin","display_name":"digital twin","score":0.8460000157356262},{"id":"https://openalex.org/keywords/fda-regulation","display_name":"FDA regulation","score":0.35499998927116394},{"id":"https://openalex.org/keywords/model-informed-drug-development","display_name":"model-informed drug development","score":0.9350000023841858},{"id":"https://openalex.org/keywords/digital-therapeutics","display_name":"digital therapeutics","score":0.6940000057220459},{"id":"https://openalex.org/keywords/machine-learning","display_name":"machine learning","score":0.4819999933242798},{"id":"https://openalex.org/keywords/multi-omics-integration","display_name":"multi-omics integration","score":0.9760000109672546},{"id":"https://openalex.org/keywords/predictive-simulation","display_name":"predictive simulation","score":0.5809999704360962},{"id":"https://openalex.org/keywords/explainable-ai","display_name":"explainable AI","score":0.7639999985694885},{"id":"https://openalex.org/keywords/regulatory-credibility","display_name":"regulatory credibility","score":0.40799999237060547},{"id":"https://openalex.org/keywords/drug-discovery","display_name":"drug discovery","score":0.6470000147819519},{"id":"https://openalex.org/keywords/personalized-medicine","display_name":"personalized medicine","score":0.5090000033378601},{"id":"https://openalex.org/keywords/neurology","display_name":"neurology","score":0.9919999837875366}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9065820574760437},{"id":"https://openalex.org/C2775905019","wikidata":"https://www.wikidata.org/wiki/Q192572","display_name":"In silico","level":3,"score":0.7001765966415405},{"id":"https://openalex.org/C64903051","wikidata":"https://www.wikidata.org/wiki/Q2198549","display_name":"Drug development","level":3,"score":0.5917967557907104},{"id":"https://openalex.org/C154690210","wikidata":"https://www.wikidata.org/wiki/Q1668499","display_name":"Rewriting","level":2,"score":0.5894726514816284},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.4422215223312378},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.42095035314559937},{"id":"https://openalex.org/C70721500","wikidata":"https://www.wikidata.org/wiki/Q177005","display_name":"Computational biology","level":1,"score":0.39742422103881836},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.3131358325481415},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.14926451444625854},{"id":"https://openalex.org/C54355233","wikidata":"https://www.wikidata.org/wiki/Q7162","display_name":"Genetics","level":1,"score":0.11722725629806519},{"id":"https://openalex.org/C199360897","wikidata":"https://www.wikidata.org/wiki/Q9143","display_name":"Programming language","level":1,"score":0.10835346579551697},{"id":"https://openalex.org/C104317684","wikidata":"https://www.wikidata.org/wiki/Q7187","display_name":"Gene","level":2,"score":0.06352677941322327},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.0},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.0}],"mesh":[],"locations_count":3,"locations":[{"id":"doi:10.7759/cureus.84007","doi":"https://doi.org/10.7759/cureus.84007","is_oa":true,"landing_page_url":"https://doi.org/10.7759/cureus.84007","pdf_url":"https://assets.cureus.com/uploads/editorial/pdf/366260/20250513-657042-ma3ego.pdf","source":{"id":"https://openalex.org/S2738950867","display_name":"Cureus","issn_l":"2168-8184","issn":["2168-8184"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","poland-20","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310316779","host_organization_name":"Cureus, Inc.","host_organization_lineage":["https://openalex.org/P4310316779"],"host_organization_lineage_names":["Cureus, Inc."],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Cureus","raw_type":"journal-article"},{"id":"pmid:40364863","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/40364863","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":"Cureus","raw_type":"Editorial"},{"id":"pmh:oai:pubmedcentral.nih.gov:12070237","doi":null,"is_oa":true,"landing_page_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC12070237/","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":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Cureus","raw_type":"Text"}],"best_oa_location":{"id":"doi:10.7759/cureus.84007","doi":"https://doi.org/10.7759/cureus.84007","is_oa":true,"landing_page_url":"https://doi.org/10.7759/cureus.84007","pdf_url":"https://assets.cureus.com/uploads/editorial/pdf/366260/20250513-657042-ma3ego.pdf","source":{"id":"https://openalex.org/S2738950867","display_name":"Cureus","issn_l":"2168-8184","issn":["2168-8184"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","poland-20","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310316779","host_organization_name":"Cureus, Inc.","host_organization_lineage":["https://openalex.org/P4310316779"],"host_organization_lineage_names":["Cureus, Inc."],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Cureus","raw_type":"journal-article"},"sustainable_development_goals":[],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4410325596.pdf","grobid_xml":"https://content.openalex.org/works/W4410325596.grobid-xml"},"referenced_works_count":14,"referenced_works":["https://openalex.org/W1997362383","https://openalex.org/W2015484447","https://openalex.org/W2063808031","https://openalex.org/W3164820824","https://openalex.org/W3211795435","https://openalex.org/W4385459199","https://openalex.org/W4388079620","https://openalex.org/W4389236503","https://openalex.org/W4393094536","https://openalex.org/W4400112692","https://openalex.org/W4402603305","https://openalex.org/W4408059532","https://openalex.org/W4409662307","https://openalex.org/W4410188281"],"related_works":["https://openalex.org/W7125797049","https://openalex.org/W4386704868","https://openalex.org/W4205787798","https://openalex.org/W7214324637","https://openalex.org/W2345592718","https://openalex.org/W7124461306","https://openalex.org/W4389440976","https://openalex.org/W7156099687","https://openalex.org/W7214683873","https://openalex.org/W7213542842"],"abstract_inverted_index":{"Recent":[0],"advances":[1],"in":[2,23,54,98,138,165],"computational":[3],"biology,":[4],"artificial":[5],"intelligence":[6],"(AI),":[7],"and":[8,19,32,91,115,129,145,160],"regulatory":[9,92,134],"science":[10],"are":[11,66,101],"rapidly":[12],"displacing":[13],"the":[14,29,69,94,153],"traditional":[15],"reliance":[16],"on":[17,85],"animal":[18,43],"early-phase":[20],"human":[21,79],"trials":[22],"drug":[24,47,117,143],"development.":[25],"In":[26],"April":[27],"2025,":[28],"U.S.":[30],"Food":[31],"Drug":[33],"Administration":[34],"announced":[35],"a":[36,50,173],"landmark":[37],"decision":[38],"to":[39,107,163,176],"phase":[40],"out":[41],"mandatory":[42],"testing":[44],"for":[45],"many":[46],"types,":[48],"signaling":[49],"paradigm":[51],"shift":[52],"toward":[53],"silico":[55,99,166],"methodologies.":[56],"This":[57],"editorial":[58,95,149],"explores":[59],"how":[60],"computer-based":[61],"models,":[62],"especially":[63],"digital":[64,146],"twins,":[65],"emerging":[67],"as":[68,141],"fourth":[70],"pillar":[71],"of":[72,76,155],"biomedical":[73],"science,":[74],"capable":[75],"simulating":[77],"complex":[78],"systems":[80],"with":[81],"remarkable":[82],"accuracy.":[83],"Drawing":[84],"real-world":[86],"examples":[87],"from":[88],"oncology,":[89],"neurology,":[90],"submissions,":[93],"argues":[96],"that":[97],"tools":[100],"no":[102,181],"longer":[103,182],"ancillary":[104],"but":[105],"central":[106],"modern":[108],"research.":[109],"These":[110],"technologies":[111],"enable":[112],"rapid,":[113],"ethical,":[114],"cost-effective":[116],"discovery":[118],"while":[119],"offering":[120],"personalized":[121],"therapeutic":[122],"insights.":[123],"As":[124],"machine":[125],"learning,":[126],"multi-omics":[127],"integration,":[128],"predictive":[130],"simulations":[131],"mature,":[132],"their":[133],"credibility":[135],"grows,":[136],"particularly":[137],"initiatives":[139],"such":[140],"model-informed":[142],"development":[144],"therapeutics.":[147],"The":[148],"concludes":[150],"by":[151],"urging":[152],"adoption":[154],"standardized":[156],"frameworks,":[157],"explainable":[158],"AI,":[159],"infrastructure":[161],"investment":[162],"ensure":[164],"research":[167],"fulfills":[168],"its":[169],"transformative":[170],"potential.":[171],"Within":[172],"decade,":[174],"failure":[175],"employ":[177],"these":[178],"methods":[179],"may":[180,187],"be":[183,188],"merely":[184],"outdated,":[185],"it":[186],"indefensible.":[189]},"counts_by_year":[{"year":2026,"cited_by_count":5},{"year":2025,"cited_by_count":1}],"updated_date":"2026-11-12T12:28:57.059296","created_date":"2025-05-14T00:00:00"}
