Proposed adapted REMARK criteria for evaluating biomarker efficacy
| Classification | Recommendation | Prospectively design* | Control arm** | Validation set*** |
|---|---|---|---|---|
| A | High | YES | YES | YES |
| B | Low | NO | YES | YES |
| C | Very low | NO | NO | NO |
* 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