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Drugs are labelled phase 1, 2 or 3 so everyone knows how proven they are. Biomarkers should carry a comparable grade, from B1 discovery to B5 utility shown in a randomised trial, so that a marker with only discovery-stage evidence is not mistaken for a validated one in guidelines and papers.
Biomarker development stages exist in the literature (discovery, analytical validation, clinical validation, clinical utility, as in the Early Detection Research Network's five phases) but are not applied to published claims or guideline statements. A simple grading (B1 discovery, B2 analytically validated, B3 clinically validated retrospectively, B4 prospectively validated, B5 utility shown in a randomised trial) attached to biomarker entries in guidelines, knowledge bases and papers would make the evidence gap visible.
Shares NCCN Guidelines, ESMO Clinical Practice Guidelines & MCBS, Knowledge reaches practice too slowly.
Shares NCCN Guidelines, ESMO Clinical Practice Guidelines & MCBS, Knowledge reaches practice too slowly.
Shares NCCN Guidelines, ESMO Clinical Practice Guidelines & MCBS, Knowledge reaches practice too slowly.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Knowledge reaches practice too slowly, Biomarkers are not validated or standardised.
Shares NCCN Guidelines, ESMO Clinical Practice Guidelines & MCBS.
Shares NCCN Guidelines, Knowledge reaches practice too slowly.
Shares NCCN Guidelines, ESMO Clinical Practice Guidelines & MCBS.
Shares NCCN Guidelines, Knowledge reaches practice too slowly.