{"id":"https://openalex.org/W4412488253","doi":"https://doi.org/10.1007/s10916-025-02231-x","title":"Why Clinical Trials Will Fail to Ensure Safe AI","display_name":"Why Clinical Trials Will Fail to Ensure Safe AI","publication_year":2025,"publication_date":"2025-07-17","ids":{"openalex":"https://openalex.org/W4412488253","doi":"https://doi.org/10.1007/s10916-025-02231-x","pmid":"https://pubmed.ncbi.nlm.nih.gov/40670886"},"language":"en","primary_location":{"id":"doi:10.1007/s10916-025-02231-x","is_oa":false,"landing_page_url":"https://doi.org/10.1007/s10916-025-02231-x","pdf_url":null,"source":{"id":"https://openalex.org/S37151855","display_name":"Journal of Medical Systems","issn_l":"0148-5598","issn":["0148-5598","1573-689X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Medical Systems","raw_type":"journal-article"},"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/A5105768006","display_name":"David P. W. Rastall","orcid":"https://orcid.org/0000-0002-6374-9073"},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"David P. W. Rastall","raw_affiliation_strings":["Armstrong Institute AI, Johns Hopkins University School of Medicine, Baltimore, MD, USA. drastal1@jhmi.edu","Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. drastal1@jhmi.edu"],"affiliations":[{"raw_affiliation_string":"Armstrong Institute AI, Johns Hopkins University School of Medicine, Baltimore, MD, USA. drastal1@jhmi.edu","institution_ids":[]},{"raw_affiliation_string":"Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. drastal1@jhmi.edu","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5091885119","display_name":"Mohamed Rehman","orcid":"https://orcid.org/0000-0003-4138-9895"},"institutions":[{"id":"https://openalex.org/I2799853436","display_name":"Johns Hopkins Medicine","ror":"https://ror.org/037zgn354","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I2799853436"]},{"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"]},{"id":"https://openalex.org/I4210098865","display_name":"Johns Hopkins All Children's Hospital","ror":"https://ror.org/013x5cp73","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I2799853436","https://openalex.org/I4210098865"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Mohamed Rehman","raw_affiliation_strings":["Department of Anesthesia and Pain Medicine, Johns Hopkins All Children's Hospital, St Petersburg, FL, USA","Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA"],"affiliations":[{"raw_affiliation_string":"Department of Anesthesia and Pain Medicine, Johns Hopkins All Children's Hospital, St Petersburg, FL, USA","institution_ids":["https://openalex.org/I4210098865","https://openalex.org/I145311948"]},{"raw_affiliation_string":"Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA","institution_ids":["https://openalex.org/I2799853436","https://openalex.org/I145311948"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":["https://openalex.org/A5105768006"],"corresponding_institution_ids":[],"apc_list":{"value":3390,"currency":"EUR","value_usd":4390},"apc_paid":null,"fwci":1.3122,"has_fulltext":false,"cited_by_count":2,"citation_normalized_percentile":{"value":0.84920408,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":91,"max":99},"biblio":{"volume":"49","issue":"1","first_page":"98","last_page":"98"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11636","display_name":"Artificial Intelligence in Healthcare and Education","score":0.9969000220298767,"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"}},"topics":[{"id":"https://openalex.org/T11636","display_name":"Artificial Intelligence in Healthcare and Education","score":0.9969000220298767,"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"}},{"id":"https://openalex.org/T10582","display_name":"Ethics in Clinical Research","score":0.9868999719619751,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T12026","display_name":"Explainable Artificial Intelligence (XAI)","score":0.9722999930381775,"subfield":{"id":"https://openalex.org/subfields/1702","display_name":"Artificial Intelligence"},"field":{"id":"https://openalex.org/fields/17","display_name":"Computer Science"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.6116762757301331},{"id":"https://openalex.org/keywords/health-informatics","display_name":"Health informatics","score":0.5071661472320557},{"id":"https://openalex.org/keywords/clinical-trial","display_name":"Clinical trial","score":0.4724319875240326},{"id":"https://openalex.org/keywords/risk-analysis","display_name":"Risk analysis (engineering)","score":0.40994101762771606},{"id":"https://openalex.org/keywords/data-science","display_name":"Data science","score":0.37280887365341187},{"id":"https://openalex.org/keywords/artificial-intelligence","display_name":"Artificial intelligence","score":0.3242172300815582},{"id":"https://openalex.org/keywords/medicine","display_name":"Medicine","score":0.2846429944038391},{"id":"https://openalex.org/keywords/public-health","display_name":"Public health","score":0.11934205889701843},{"id":"https://openalex.org/keywords/pathology","display_name":"Pathology","score":0.07759687304496765}],"concepts":[{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.6116762757301331},{"id":"https://openalex.org/C145642194","wikidata":"https://www.wikidata.org/wiki/Q870895","display_name":"Health informatics","level":3,"score":0.5071661472320557},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.4724319875240326},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.40994101762771606},{"id":"https://openalex.org/C2522767166","wikidata":"https://www.wikidata.org/wiki/Q2374463","display_name":"Data science","level":1,"score":0.37280887365341187},{"id":"https://openalex.org/C154945302","wikidata":"https://www.wikidata.org/wiki/Q11660","display_name":"Artificial intelligence","level":1,"score":0.3242172300815582},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.2846429944038391},{"id":"https://openalex.org/C138816342","wikidata":"https://www.wikidata.org/wiki/Q189603","display_name":"Public health","level":2,"score":0.11934205889701843},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.07759687304496765}],"mesh":[{"descriptor_ui":"D001185","descriptor_name":"Artificial Intelligence","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D001185","descriptor_name":"Artificial Intelligence","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D001185","descriptor_name":"Artificial Intelligence","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D006801","descriptor_name":"Humans","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":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D061214","descriptor_name":"Patient Safety","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D061214","descriptor_name":"Patient Safety","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D061214","descriptor_name":"Patient Safety","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.1007/s10916-025-02231-x","is_oa":false,"landing_page_url":"https://doi.org/10.1007/s10916-025-02231-x","pdf_url":null,"source":{"id":"https://openalex.org/S37151855","display_name":"Journal of Medical Systems","issn_l":"0148-5598","issn":["0148-5598","1573-689X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310319900","host_organization_name":"Springer Science+Business Media","host_organization_lineage":["https://openalex.org/P4310319900","https://openalex.org/P4310319965"],"host_organization_lineage_names":["Springer Science+Business Media","Springer Nature"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Medical Systems","raw_type":"journal-article"},{"id":"pmid:40670886","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/40670886","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,"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":"Journal of medical systems","raw_type":null}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.5400000214576721,"display_name":"Peace, Justice and strong institutions","id":"https://metadata.un.org/sdg/16"}],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":7,"referenced_works":["https://openalex.org/W3174786846","https://openalex.org/W4206698631","https://openalex.org/W4253763531","https://openalex.org/W4323050332","https://openalex.org/W4391833135","https://openalex.org/W4402559330","https://openalex.org/W4410079576"],"related_works":["https://openalex.org/W4409308761","https://openalex.org/W4393234404","https://openalex.org/W2124655189","https://openalex.org/W4401284225","https://openalex.org/W2330369487","https://openalex.org/W2906196243","https://openalex.org/W1993282409","https://openalex.org/W4385765419","https://openalex.org/W2983008726","https://openalex.org/W2003798170"],"abstract_inverted_index":null,"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2025,"cited_by_count":1}],"updated_date":"2026-03-29T08:15:47.926485","created_date":"2025-10-10T00:00:00"}
