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Trials that only enrol patients with a positive biomarker can never prove the biomarker matters. Including a smaller biomarker-negative group would show whether the test is really needed.
Enrichment designs enrol only biomarker-positive patients and cannot estimate the interaction between marker and treatment. Marker-stratified designs (all-comers with stratified randomisation and pre-specified interaction tests) are the accepted way to validate a predictive biomarker but are rarely used because they cost more. Regulators could require a marker-negative cohort (even under-powered but pooled across trials) whenever a biomarker is proposed to restrict a label, so the restriction is evidence-based.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Hazard ratio (HR), Biomarkers are not validated or standardised, Trial design, endpoints and cost.
Shares Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Companion diagnostic, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Companion diagnostic, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Homologous recombination deficiency (HRD), Biomarkers are not validated or standardised.