Proposed adapted REMARK criteria for evaluating biomarker efficacy

ClassificationRecommendationProspectively design*Control arm**Validation set***
AHighYESYESYES
BLowNOYES YES
CVery lowNONONO

* Includes a prospective sample size for the biomarker, with pre-defined differences in PFS and/or OS (HR) after adjusting with other variables in advanced disease or pre-defined differences on pathological complete response in neoadjuvant setting. ** Control arm. Exposure to other therapies to evaluate if the effect is prognostic or predictive. *** Validation set. Use of at least one additional set with the same biomarker and cut-off. PFS: progression-free survival; OS: overall survival; HR: hazard ratio