{"entity":{"id":"idea-tr2-biomarker-study-registry","kind":"idea","name":"Pre-register biomarker validation studies the way trials are registered","aka":[],"tldr":"Drug trials must be registered before they start so results cannot be hidden or reshaped. Studies that claim a biomarker predicts outcome should be registered too.","summary":"Biomarker studies suffer from selective reporting, flexible cut-points and unreported failed validations. A registry for biomarker validation studies (marker, assay, population, pre-specified analysis and cut-point, primary performance measure), required by journals for prognostic and predictive claims, would enable tracking of validation attempts including the negative ones, and reduce analytic flexibility.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Biomarkers are not validated or standardised): Fernandez et al., Examination of low ERBB2 protein expression in breast cancer tissue (JAMA Oncology 2022)","url":"https://doi.org/10.1001/jamaoncol.2021.7239"}],"tags":[],"related":["clinicaltrials-gov","idea-tr2-preclinical-registered-reports"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-biomarker-validation","b-reproducibility"],"keyPapers":["paper-fernandez-jama-oncol"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Registered biomarker studies will report smaller effect sizes on average than unregistered studies of the same markers, and the proportion of validated biomarkers that replicate will rise.","rationale":"Trial registration reduced positive reporting bias in clinical trials; the same mechanism applies to observational biomarker research, as the REMARK and TRIPOD guidelines argue.","test":"Launch the registry with two journals requiring registration; compare reported effect sizes and replication rates over three years.","maturity":"speculative","actor":"policy","cost":"small","horizonYears":2},"route":"/ideas/idea-tr2-biomarker-study-registry/","neighbours":{"collection":[{"id":"clinicaltrials-gov","kind":"collection","name":"ClinicalTrials.gov","route":"/collections/clinicaltrials-gov/"}],"idea":[{"id":"idea-tr2-preclinical-registered-reports","kind":"idea","name":"Registered reports for cancer biology: the plan is peer-reviewed before the result","route":"/ideas/idea-tr2-preclinical-registered-reports/"}],"bottleneck":[{"id":"b-biomarker-validation","kind":"bottleneck","name":"Biomarkers are not validated or standardised","route":"/bottlenecks/b-biomarker-validation/"},{"id":"b-reproducibility","kind":"bottleneck","name":"Preclinical results do not reproduce","route":"/bottlenecks/b-reproducibility/"}],"paper":[{"id":"paper-fernandez-jama-oncol","kind":"paper","name":"Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue","route":"/key-papers/paper-fernandez-jama-oncol/"}],"roadmap":[{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"}]}}