ESMO basic requirements for AI-based biomarkers in oncology (EBAI)

Artificial intelligence; Biomarker; Cancer

Detalles Bibliográficos
Autores: Aldea, Mihaela, Salto-Tellez, Manuel, Marra, Antonio, Umeton, Renato, Stenzinger, Albrecht, Koopman, Miriam, Mateo, Joaquin, Perez-Lopez, Raquel
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2026
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:dnet:recercat____::793d4a04a112648fb6e7ae05002d2e33
Acceso en línea:http://hdl.handle.net/11351/14589
https://hdl.handle.net/11351/14589
Access Level:acceso abierto
Palabra clave:Càncer
Marcadors tumorals
Intel·ligència artificial
Mètode Delphi
PHENOMENA AND PROCESSES::Mathematical Concepts::Algorithms::Artificial Intelligence
CHEMICALS AND DRUGS::Biological Factors::Biomarkers::Biomarkers, Tumor
INFORMATION SCIENCE::Information Science::Systems Analysis::Delphi Technique
DISCIPLINES AND OCCUPATIONS::Health Occupations::Medicine::Internal Medicine::Medical Oncology
DISEASES::Neoplasms
FENÓMENOS Y PROCESOS::conceptos matemáticos::algoritmos::inteligencia artificial
COMPUESTOS QUÍMICOS Y DROGAS::factores biológicos::biomarcadores::marcadores tumorales
CIENCIA DE LA INFORMACIÓN::Ciencias de la información::análisis de sistemas::técnica Delfos
DISCIPLINAS Y OCUPACIONES::profesiones sanitarias::medicina::medicina interna::oncología médica
ENFERMEDADES::neoplasias
id ES_57db51cd645c8d7bd81fa6d6adad3c92
oai_identifier_str oai:dnet:recercat____::793d4a04a112648fb6e7ae05002d2e33
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv ESMO basic requirements for AI-based biomarkers in oncology (EBAI)
title ESMO basic requirements for AI-based biomarkers in oncology (EBAI)
spellingShingle ESMO basic requirements for AI-based biomarkers in oncology (EBAI)
Aldea, Mihaela
Càncer
Marcadors tumorals
Intel·ligència artificial
Mètode Delphi
PHENOMENA AND PROCESSES::Mathematical Concepts::Algorithms::Artificial Intelligence
CHEMICALS AND DRUGS::Biological Factors::Biomarkers::Biomarkers, Tumor
INFORMATION SCIENCE::Information Science::Systems Analysis::Delphi Technique
DISCIPLINES AND OCCUPATIONS::Health Occupations::Medicine::Internal Medicine::Medical Oncology
DISEASES::Neoplasms
FENÓMENOS Y PROCESOS::conceptos matemáticos::algoritmos::inteligencia artificial
COMPUESTOS QUÍMICOS Y DROGAS::factores biológicos::biomarcadores::marcadores tumorales
CIENCIA DE LA INFORMACIÓN::Ciencias de la información::análisis de sistemas::técnica Delfos
DISCIPLINAS Y OCUPACIONES::profesiones sanitarias::medicina::medicina interna::oncología médica
ENFERMEDADES::neoplasias
title_short ESMO basic requirements for AI-based biomarkers in oncology (EBAI)
title_full ESMO basic requirements for AI-based biomarkers in oncology (EBAI)
title_fullStr ESMO basic requirements for AI-based biomarkers in oncology (EBAI)
title_full_unstemmed ESMO basic requirements for AI-based biomarkers in oncology (EBAI)
title_sort ESMO basic requirements for AI-based biomarkers in oncology (EBAI)
dc.creator.none.fl_str_mv Aldea, Mihaela
Salto-Tellez, Manuel
Marra, Antonio
Umeton, Renato
Stenzinger, Albrecht
Koopman, Miriam
Mateo, Joaquin
Perez-Lopez, Raquel
author Aldea, Mihaela
author_facet Aldea, Mihaela
Salto-Tellez, Manuel
Marra, Antonio
Umeton, Renato
Stenzinger, Albrecht
Koopman, Miriam
Mateo, Joaquin
Perez-Lopez, Raquel
author_role author
author2 Salto-Tellez, Manuel
Marra, Antonio
Umeton, Renato
Stenzinger, Albrecht
Koopman, Miriam
Mateo, Joaquin
Perez-Lopez, Raquel
author2_role author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[Aldea M] Department of Cancer Medicine, Gustave Roussy, Villejuif, France. Faculty of Medicine, Paris-Saclay University, Kremlin Bicêtre, France. Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Boston, USA. [Salto-Tellez M] Patrick G Johnston Centre for Cancer Research, Queen’s University Belfast, Belfast, UK. Joint Integrated Pathology Unit, The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust, London, UK. [Marra A] Division of Early Drug Development for Innovative Therapies, European Institute of Oncology IRCCS, Milan, Italy. Department of Oncology and Hemato-Oncology, University of Milano, Milan, Italy. [Umeton R] Office of Data Science, St. Jude Children’s Research Hospital, Memphis, USA. Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, USA. Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, USA. Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, USA. Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, USA. [Stenzinger A] Institute of Pathology, University Hospital Heidelberg and Center for Personalized Medicine (ZPM), Heidelberg, Germany. [Koopman M] Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. [Mateo J] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Perez-Lopez R] Radiomics Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Càncer
Marcadors tumorals
Intel·ligència artificial
Mètode Delphi
PHENOMENA AND PROCESSES::Mathematical Concepts::Algorithms::Artificial Intelligence
CHEMICALS AND DRUGS::Biological Factors::Biomarkers::Biomarkers, Tumor
INFORMATION SCIENCE::Information Science::Systems Analysis::Delphi Technique
DISCIPLINES AND OCCUPATIONS::Health Occupations::Medicine::Internal Medicine::Medical Oncology
DISEASES::Neoplasms
FENÓMENOS Y PROCESOS::conceptos matemáticos::algoritmos::inteligencia artificial
COMPUESTOS QUÍMICOS Y DROGAS::factores biológicos::biomarcadores::marcadores tumorales
CIENCIA DE LA INFORMACIÓN::Ciencias de la información::análisis de sistemas::técnica Delfos
DISCIPLINAS Y OCUPACIONES::profesiones sanitarias::medicina::medicina interna::oncología médica
ENFERMEDADES::neoplasias
topic Càncer
Marcadors tumorals
Intel·ligència artificial
Mètode Delphi
PHENOMENA AND PROCESSES::Mathematical Concepts::Algorithms::Artificial Intelligence
CHEMICALS AND DRUGS::Biological Factors::Biomarkers::Biomarkers, Tumor
INFORMATION SCIENCE::Information Science::Systems Analysis::Delphi Technique
DISCIPLINES AND OCCUPATIONS::Health Occupations::Medicine::Internal Medicine::Medical Oncology
DISEASES::Neoplasms
FENÓMENOS Y PROCESOS::conceptos matemáticos::algoritmos::inteligencia artificial
COMPUESTOS QUÍMICOS Y DROGAS::factores biológicos::biomarcadores::marcadores tumorales
CIENCIA DE LA INFORMACIÓN::Ciencias de la información::análisis de sistemas::técnica Delfos
DISCIPLINAS Y OCUPACIONES::profesiones sanitarias::medicina::medicina interna::oncología médica
ENFERMEDADES::neoplasias
description Artificial intelligence; Biomarker; Cancer
publishDate 2026
dc.date.none.fl_str_mv 2026
2026
2026
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11351/14589
https://hdl.handle.net/11351/14589
url http://hdl.handle.net/11351/14589
https://hdl.handle.net/11351/14589
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Annals of Oncology;37(3)
https://doi.org/10.1016/j.annonc.2025.11.009
dc.rights.none.fl_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv Scientia
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869408482213494784
spelling ESMO basic requirements for AI-based biomarkers in oncology (EBAI)Aldea, MihaelaSalto-Tellez, ManuelMarra, AntonioUmeton, RenatoStenzinger, AlbrechtKoopman, MiriamMateo, JoaquinPerez-Lopez, RaquelCàncerMarcadors tumoralsIntel·ligència artificialMètode DelphiPHENOMENA AND PROCESSES::Mathematical Concepts::Algorithms::Artificial IntelligenceCHEMICALS AND DRUGS::Biological Factors::Biomarkers::Biomarkers, TumorINFORMATION SCIENCE::Information Science::Systems Analysis::Delphi TechniqueDISCIPLINES AND OCCUPATIONS::Health Occupations::Medicine::Internal Medicine::Medical OncologyDISEASES::NeoplasmsFENÓMENOS Y PROCESOS::conceptos matemáticos::algoritmos::inteligencia artificialCOMPUESTOS QUÍMICOS Y DROGAS::factores biológicos::biomarcadores::marcadores tumoralesCIENCIA DE LA INFORMACIÓN::Ciencias de la información::análisis de sistemas::técnica DelfosDISCIPLINAS Y OCUPACIONES::profesiones sanitarias::medicina::medicina interna::oncología médicaENFERMEDADES::neoplasiasArtificial intelligence; Biomarker; CancerIntel·ligència artificial; Biomarcador; CàncerInteligencia artificial; Biomarcador; CáncerBackground: Artificial intelligence (AI) is expected to introduce an increasing number of biomarkers in oncology. To bridge the gap between oncology and computer science, it is timely to define recommendations for AI-based biomarkers suitable for routine clinical use. Here, we propose the ESMO (European Society for Medical Oncology) Basic Requirements for AI-based Biomarkers In Oncology (EBAI). Design: The EBAI framework was developed using a modified Delphi methodology, involving a multidisciplinary panel of 37 experts who participated in four structured consensus rounds. Results: AI-based biomarkers were classified as 'class A' (AI quantification of established biomarkers), 'class B' (indirect measure of known biomarkers using AI-based alternative methods, to be deployed as pre-screening tests), and 'class C' (novel AI-derived biomarkers, with C1 for prognosis and C2 for prediction of treatment effect). The EBAI framework addresses AI biomarkers for clinical use. Ground truth, performance, and generalisability were considered essential; fairness was recommended. Minimal validation requirements indicate that class A requires concordance studies, class B analytical validation, class C1 high-quality retrospective real-world or clinical trial data, and class C2 additionally requires clinical validation in prospective clinical trials for the prediction of response to a new treatment. All biomarker studies should report multiple evaluation and calibration metrics, with a clearly defined primary objective. Generalisability should be demonstrated across all intended use settings, including variability in data acquisition, post-processing, and population characteristics. Biomarkers must not be applied to other cancer types or modalities without supporting evidence. Conclusions: EBAI defines criteria for AI-based biomarker adoption in routine use, providing a common language for physicians, AI developers, and researchers.This work was supported by the European Society for Medical Oncology (no grant number).ElsevierInstitut Català de la Salut[Aldea M] Department of Cancer Medicine, Gustave Roussy, Villejuif, France. Faculty of Medicine, Paris-Saclay University, Kremlin Bicêtre, France. Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Boston, USA. [Salto-Tellez M] Patrick G Johnston Centre for Cancer Research, Queen’s University Belfast, Belfast, UK. Joint Integrated Pathology Unit, The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust, London, UK. [Marra A] Division of Early Drug Development for Innovative Therapies, European Institute of Oncology IRCCS, Milan, Italy. Department of Oncology and Hemato-Oncology, University of Milano, Milan, Italy. [Umeton R] Office of Data Science, St. Jude Children’s Research Hospital, Memphis, USA. Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, USA. Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, USA. Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, USA. Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, USA. [Stenzinger A] Institute of Pathology, University Hospital Heidelberg and Center for Personalized Medicine (ZPM), Heidelberg, Germany. [Koopman M] Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. [Mateo J] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Perez-Lopez R] Radiomics Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, SpainVall d'Hebron Barcelona Hospital Campus202620262026info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttp://hdl.handle.net/11351/14589https://hdl.handle.net/11351/14589Scientiareponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésAnnals of Oncology;37(3)https://doi.org/10.1016/j.annonc.2025.11.009Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:dnet:recercat____::793d4a04a112648fb6e7ae05002d2e332026-05-29T05:05:01Z
score 15,812429