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Companies sometimes choose the biomarker threshold that makes their trial look best after seeing the data. Requiring the threshold to be fixed and published before the big trial starts prevents this.
Cut-points for continuous biomarkers (PD-L1 percentages, HER2-low boundaries, ctDNA thresholds) are frequently selected from phase 2 data with multiple thresholds explored, and sometimes revised during phase 3. Regulators could require that the phase 3 protocol specify the cut-point and the assay version, derived from an independent training set, with the derivation report deposited in the trial registry before enrolment.
Shares Test the drug in biomarker-negative patients too, so the biomarker can be validated, Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Biomarkers are not validated or standardised, PD-L1.
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, Companion diagnostic, 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, Companion diagnostic, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Biomarkers are not validated or standardised, Trial design, endpoints and cost.
Shares Companion diagnostic, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Biomarkers are not validated or standardised.