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

Publikation: Beitrag in FachzeitschriftForschungsartikelBeigetragenBegutachtung

Beitragende

  • M Aldea - , Institut Gustave Roussy, Université Paris-Saclay, Dana-Farber Cancer Institute (Autor:in)
  • M Salto-Tellez - , Queen's University Belfast, Royal Marsden NHS Foundation Trust (Autor:in)
  • A Marra - , IRCCS Istituto Europeo di Oncologia - Milano, Università degli Studi di Milano (Autor:in)
  • R Umeton - , St. Jude Children Research Hospital, Massachusetts Institute of Technology (MIT), Weill Cornell Medicine, Harvard University (Autor:in)
  • A Stenzinger - , Weill Cornell Medicine (Autor:in)
  • M Koopman - , Universitätsklinikum Utrecht (Autor:in)
  • A Prelaj - , IRCCS Fondazione Istituto Nazionale per lo studio e la cura dei tumori - Milano, Polytechnic University of Milan (Autor:in)
  • K L Kehl - , Dana-Farber Cancer Institute (Autor:in)
  • S Gilbert - , Else Kröner Fresenius Zentrum für Digitale Gesundheit (Autor:in)
  • M-E Leßmann - , Else Kröner Fresenius Zentrum für Digitale Gesundheit (Autor:in)
  • J Lipkova - , University of California at Irvine, UCI Health Chao Family Comprehensive Cancer Center (Autor:in)
  • L Provenzano - , IRCCS Fondazione Istituto Nazionale per lo studio e la cura dei tumori - Milano, Polytechnic University of Milan (Autor:in)
  • F Meric-Bernstam - , University of Texas MD Anderson Cancer Center (Autor:in)
  • S Halabi - , Duke University (Autor:in)
  • J Wu - , Duke University, University of Texas MD Anderson Cancer Center (Autor:in)
  • A Pellat - , Hôpital Cochin (Autor:in)
  • K P M Suijkerbuijk - , Universitätsklinikum Utrecht (Autor:in)
  • B Besse - , Institut Gustave Roussy, Université Paris-Saclay (Autor:in)
  • B Ryll - , Melanoma Patient Network Europe (Autor:in)
  • C Marchió - , University of Turin, Istituto di Candiolo FPO-IRCCS (Autor:in)
  • M Crispin-Ortuzar - , University of Cambridge (Autor:in)
  • R Fehrmann - , University of Groningen (Autor:in)
  • J Vibert - , Institut Gustave Roussy (Autor:in)
  • D Ferber - , Nationales Zentrum für Tumorerkrankungen (NCT) Heidelberg (Autor:in)
  • C Pauli - , Universität Zürich (Autor:in)
  • A Valachis - , Örebro University (Autor:in)
  • F Corso - , IRCCS Fondazione Istituto Nazionale per lo studio e la cura dei tumori - Milano (Autor:in)
  • T J Brinker - , Deutsches Krebsforschungszentrum (DKFZ) (Autor:in)
  • J Mateo - , Hospital Universitari Vall d'Hebron (Autor:in)
  • N Harbeck - , Universidad Complutense de Madrid (Autor:in)
  • E C Winkler - , Nationales Zentrum für Tumorerkrankungen (NCT) Heidelberg (Autor:in)
  • F Lopez-Rios - , Universidad Complutense de Madrid (Autor:in)
  • R Perez-Lopez - , Vall d'Hebron Institute of Oncology (VHIO) (Autor:in)
  • G Pentheroudakis - , European Society for Medical Oncology (Autor:in)
  • S Delaloge - , Institut Gustave Roussy (Autor:in)
  • C Benedikt Westphalen - , Ludwig-Maximilians-Universität München (LMU), Deutsches Konsortium für Translationale Krebsforschung (DKTK) - München (Autor:in)
  • J N Kather - , Else Kröner Fresenius Zentrum für Digitale Gesundheit, Nationales Zentrum für Tumorerkrankungen (NCT) Heidelberg, University of Leeds (Autor:in)

Abstract

BACKGROUND 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 Basic Requirements for AI-based Biomarkers In Oncology (EBAI). METHODS The EBAI framework was developed using a modified Delphi methodology, involving a multidisciplinary panel of 37 experts who participated in three 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. CONCLUSION EBAI defines criteria for AI-based biomarker adoption in routine use, providing a common language for physicians, AI developers, and researchers.

Details

OriginalspracheEnglisch
Seiten (von - bis)414-430
Seitenumfang17
FachzeitschriftAnnals of Oncology
Jahrgang37
Ausgabenummer3
Frühes Online-Datum18 Nov. 2025
PublikationsstatusVeröffentlicht - März 2026
Peer-Review-StatusJa

Externe IDs

ORCID /0000-0002-3730-5348/work/201625048
ORCID /0000-0002-1997-1689/work/201625057
ORCID /0009-0005-7029-0028/work/201625158
Mendeley ffcc9006-7988-3a71-9714-ceb17a7f3a2b
Scopus 105030165164

Schlagworte

Ziele für nachhaltige Entwicklung

Schlagwörter

  • Artificial Intelligence/standards, Biomarkers, Tumor/analysis, Delphi Technique, Europe, Humans, Medical Oncology/methods, Neoplasms/diagnosis, Prognosis, Societies, Medical, EBAI, scale, biomarker, artificial intelligence, cancer, validation