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

作者：Mihaela Aldea, Manuel Salto‐Tellez, Antonio Marra, Renato Umeton, Albrecht Stenzinger, Miriam Koopman, Arsela Prelaj, Kenneth L. Kehl, Stephen Gilbert, M. Leßmann, Jolana Lipková, Leonardo Provenzano, F. Meric-Bernstam, Susan Halabi, Jianrong Wu, Anna Pellat, Karijn P.M. Suijkerbuijk, B. Besse, Bettina Ryll, Caterina Marchiò, Mireia Crispin‐Ortuzar, Rudolf S.N. Fehrmann, Julien Vibert, Dyke Ferber, Chantal Pauli, Antonios Valachis, Federica Corso, Titus J. Brinker, Joaquı́n Mateo, Nadia Harbeck, Eva C. Winkler, Fernando López‐Ríos, Raquel Pérez-López, George Pentheroudakis, Suzette Delaloge, C. Benedikt Westphalen, Jakob Nikolas Kather · 发表于：Annals of Oncology · 年份：2025 · DOI：10.1016/j.annonc.2025.11.009 · 被引用次数：37 · 研究领域：Artificial Intelligence in Healthcare and Education、Radiomics and Machine Learning in Medical Imaging、Explainable Artificial Intelligence (XAI)

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 (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 ...