{"id":"https://openalex.org/W4417480602","doi":"https://doi.org/10.1016/j.jval.2025.09.1633","title":"HPR226 Uncertainties in Regulatory Benefit-Risk Decision Making for Innovative Anticancer Therapies: Preliminary Results From a 2011-2024 Review of Extensions of Indications","display_name":"HPR226 Uncertainties in Regulatory Benefit-Risk Decision Making for Innovative Anticancer Therapies: Preliminary Results From a 2011-2024 Review of Extensions of Indications","publication_year":2025,"publication_date":"2025-12-01","ids":{"openalex":"https://openalex.org/W4417480602","doi":"https://doi.org/10.1016/j.jval.2025.09.1633"},"language":"en","primary_location":{"id":"doi:10.1016/j.jval.2025.09.1633","doi":"https://doi.org/10.1016/j.jval.2025.09.1633","is_oa":false,"landing_page_url":"https://doi.org/10.1016/j.jval.2025.09.1633","pdf_url":null,"source":{"id":"https://openalex.org/S678965","display_name":"Value in Health","issn_l":"1098-3015","issn":["1098-3015","1524-4733"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["abdc-a","anvur-class-a","anvur-scientific","cwts-core","dongbi-a","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Value in Health","raw_type":"journal-article"},"volume":null,"type":"conference-abstract","is_traditional":false,"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/A5114329689","display_name":"F\u00e1bio Cardoso Borges","orcid":"https://orcid.org/0000-0001-8496-9211","observed_orcids":["https://orcid.org/0000-0001-8496-9211"]},"institutions":[{"id":"https://openalex.org/I4210124801","display_name":"European Organisation for Research and Treatment of Cancer","ror":"https://ror.org/034wxcc35","country_code":"BE","type":"nonprofit","lineage":["https://openalex.org/I4210124801"]}],"countries":["BE"],"is_corresponding":false,"raw_author_name":"F\u00e1bio Cardoso Borges","raw_affiliation_strings":["European Organisation for Research and Treatment of Cancer, Brussels, Belgium"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"European Organisation for Research and Treatment of Cancer, Brussels, Belgium","institution_ids":["https://openalex.org/I4210124801"]}]},{"author_position":"middle","author":{"id":null,"display_name":"Luigi Lim","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210124801","display_name":"European Organisation for Research and Treatment of Cancer","ror":"https://ror.org/034wxcc35","country_code":"BE","type":"nonprofit","lineage":["https://openalex.org/I4210124801"]}],"countries":["BE"],"is_corresponding":false,"raw_author_name":"Luigi Lim","raw_affiliation_strings":["European Organisation for Research and Treatment of Cancer, Brussels, Belgium"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"European Organisation for Research and Treatment of Cancer, Brussels, Belgium","institution_ids":["https://openalex.org/I4210124801"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5069390555","display_name":"Maria Manuel Teixeira","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210124801","display_name":"European Organisation for Research and Treatment of Cancer","ror":"https://ror.org/034wxcc35","country_code":"BE","type":"nonprofit","lineage":["https://openalex.org/I4210124801"]}],"countries":["BE"],"is_corresponding":false,"raw_author_name":"Maria Manuel Teixeira","raw_affiliation_strings":["European Organisation for Research and Treatment of Cancer, Brussels, Belgium"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"European Organisation for Research and Treatment of Cancer, Brussels, Belgium","institution_ids":["https://openalex.org/I4210124801"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5017364811","display_name":"Francesco Pignatti","orcid":"https://orcid.org/0000-0001-9296-2474","observed_orcids":["https://orcid.org/0000-0001-9296-2474"]},"institutions":[{"id":"https://openalex.org/I1297934274","display_name":"European Medicines Agency","ror":"https://ror.org/01z0wsw92","country_code":"NL","type":"government","lineage":["https://openalex.org/I1297934274","https://openalex.org/I1320481043"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"Francesco Pignatti","raw_affiliation_strings":["European Medicines Agency, Amsterdam, Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"European Medicines Agency, Amsterdam, Netherlands","institution_ids":["https://openalex.org/I1297934274"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5064975295","display_name":"Madeline Lee Pe","orcid":"https://orcid.org/0009-0005-2531-0050","observed_orcids":["https://orcid.org/0009-0005-2531-0050"]},"institutions":[{"id":"https://openalex.org/I4210124801","display_name":"European Organisation for Research and Treatment of Cancer","ror":"https://ror.org/034wxcc35","country_code":"BE","type":"nonprofit","lineage":["https://openalex.org/I4210124801"]}],"countries":["BE"],"is_corresponding":false,"raw_author_name":"Madeline Pe","raw_affiliation_strings":["European Organisation for Research and Treatment of Cancer, Brussels, Belgium"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"European Organisation for Research and Treatment of Cancer, Brussels, Belgium","institution_ids":["https://openalex.org/I4210124801"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5009884013","display_name":"Caroline Voltz-Girolt","orcid":"https://orcid.org/0009-0005-2771-5713","observed_orcids":["https://orcid.org/0009-0005-2771-5713"]},"institutions":[{"id":"https://openalex.org/I1297934274","display_name":"European Medicines Agency","ror":"https://ror.org/01z0wsw92","country_code":"NL","type":"government","lineage":["https://openalex.org/I1297934274","https://openalex.org/I1320481043"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"Caroline Voltz","raw_affiliation_strings":["European Medicines Agency, Amsterdam, Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"European Medicines Agency, Amsterdam, Netherlands","institution_ids":["https://openalex.org/I1297934274"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5103260191","display_name":"Denis Lacombe","orcid":"https://orcid.org/0000-0003-1128-155X","observed_orcids":["https://orcid.org/0000-0003-1128-155X"]},"institutions":[{"id":"https://openalex.org/I4210124801","display_name":"European Organisation for Research and Treatment of Cancer","ror":"https://ror.org/034wxcc35","country_code":"BE","type":"nonprofit","lineage":["https://openalex.org/I4210124801"]}],"countries":["BE"],"is_corresponding":false,"raw_author_name":"Denis Lacombe","raw_affiliation_strings":["European Organisation for Research and Treatment of Cancer, Brussels, Belgium"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"European Organisation for Research and Treatment of Cancer, Brussels, Belgium","institution_ids":["https://openalex.org/I4210124801"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5008617034","display_name":"Carla Torre","orcid":"https://orcid.org/0000-0002-5542-9993","observed_orcids":["https://orcid.org/0000-0002-5542-9993"]},"institutions":[{"id":"https://openalex.org/I141596103","display_name":"University of Lisbon","ror":"https://ror.org/01c27hj86","country_code":"PT","type":"education","lineage":["https://openalex.org/I141596103"]}],"countries":["PT"],"is_corresponding":false,"raw_author_name":"Carla Torre","raw_affiliation_strings":["Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal","institution_ids":["https://openalex.org/I141596103"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5086547459","display_name":"Isabelle Huys","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I99464096","display_name":"KU Leuven","ror":"https://ror.org/05f950310","country_code":"BE","type":"education","lineage":["https://openalex.org/I99464096"]}],"countries":["BE"],"is_corresponding":false,"raw_author_name":"Isabelle Huys","raw_affiliation_strings":["Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium","institution_ids":["https://openalex.org/I99464096"]}]}],"institutions":[],"countries_distinct_count":3,"institutions_distinct_count":4,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":{"value":4000,"currency":"USD","value_usd":4000},"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"28","issue":"12","first_page":"S366","last_page":"S366"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10804","display_name":"Health Systems, Economic Evaluations, Quality of Life","score":0.913100004196167,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T10804","display_name":"Health Systems, Economic Evaluations, Quality of Life","score":0.913100004196167,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T11792","display_name":"Pharmaceutical Economics and Policy","score":0.05649999901652336,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T12708","display_name":"Economic and Financial Impacts of Cancer","score":0.009399999864399433,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/cancer-therapy","display_name":"cancer therapy","score":0.7900000214576721},{"id":"https://openalex.org/keywords/drug-approval","display_name":"drug approval","score":0.4970000088214874},{"id":"https://openalex.org/keywords/uncertainty","display_name":"uncertainty","score":0.453000009059906},{"id":"https://openalex.org/keywords/regulatory-decision-making","display_name":"regulatory decision-making","score":0.640999972820282},{"id":"https://openalex.org/keywords/anticancer-drug-development","display_name":"anticancer drug development","score":0.5130000114440918}],"concepts":[{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.6367999911308289},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.4496999979019165},{"id":"https://openalex.org/C539667460","wikidata":"https://www.wikidata.org/wiki/Q2414942","display_name":"Management science","level":1,"score":0.42480000853538513},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.36480000615119934},{"id":"https://openalex.org/C195094911","wikidata":"https://www.wikidata.org/wiki/Q14167904","display_name":"Process management","level":1,"score":0.29010000824928284},{"id":"https://openalex.org/C2522767166","wikidata":"https://www.wikidata.org/wiki/Q2374463","display_name":"Data science","level":1,"score":0.23980000615119934},{"id":"https://openalex.org/C201995342","wikidata":"https://www.wikidata.org/wiki/Q682496","display_name":"Systems engineering","level":1,"score":0.2296999990940094},{"id":"https://openalex.org/C56739046","wikidata":"https://www.wikidata.org/wiki/Q192060","display_name":"Knowledge management","level":1,"score":0.21389999985694885},{"id":"https://openalex.org/C2989179672","wikidata":"https://www.wikidata.org/wiki/Q6806500","display_name":"Clinical decision making","level":2,"score":0.20000000298023224},{"id":"https://openalex.org/C42475967","wikidata":"https://www.wikidata.org/wiki/Q194292","display_name":"Operations research","level":1,"score":0.18559999763965607}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1016/j.jval.2025.09.1633","doi":"https://doi.org/10.1016/j.jval.2025.09.1633","is_oa":false,"landing_page_url":"https://doi.org/10.1016/j.jval.2025.09.1633","pdf_url":null,"source":{"id":"https://openalex.org/S678965","display_name":"Value in Health","issn_l":"1098-3015","issn":["1098-3015","1524-4733"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["abdc-a","anvur-class-a","anvur-scientific","cwts-core","dongbi-a","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Value in Health","raw_type":"journal-article"}],"best_oa_location":null,"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":0.9391000270843506}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W7098900514","https://openalex.org/W4200113327","https://openalex.org/W1978076918","https://openalex.org/W6963289377","https://openalex.org/W596396523","https://openalex.org/W4410588415","https://openalex.org/W7036180694","https://openalex.org/W4232959767","https://openalex.org/W1989497622","https://openalex.org/W2050657815"],"abstract_inverted_index":null,"counts_by_year":[],"updated_date":"2026-10-12T09:40:04.860316","created_date":"2025-12-19T00:00:00"}