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Completed trials have stored samples. Testing a new biomarker on them with the plan written in advance is nearly as good as a new trial and far cheaper, but regulators have no clear route to accept it.
The prospective-retrospective design (Simon, Paik and Hayes) uses archived samples from a completed randomised trial with a pre-specified analysis plan to validate a predictive biomarker. It rescued KRAS testing for anti-EGFR antibodies and Oncotype DX. Regulators accept it case by case. A published guidance with requirements (sample availability above a threshold, pre-registered analysis plan, independent statistical execution) would make the route predictable and encourage sponsors to bank and share samples.
Shares RxPONDER (SWOG S1007), TAILORx, Oncotype DX.
Shares RxPONDER (SWOG S1007), TAILORx, Oncotype DX.
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 Rescue the biological samples from failed trials for biomarker research, Failures are hidden.
Shares TAILORx, Oncotype DX.