# Pre-register biomarker validation studies the way trials are registered

Source: https://onco.cc/ideas/idea-tr2-biomarker-study-registry/  
OnCo record `idea-tr2-biomarker-study-registry` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed test: Launch the registry with two journals requiring registration; compare reported effect sizes and replication rates over three years.
- Maturity: speculative
- Actor: policy

## Sources

- Bottleneck evidence (Biomarkers are not validated or standardised): Fernandez et al., Examination of low ERBB2 protein expression in breast cancer tissue (JAMA Oncology 2022): https://doi.org/10.1001/jamaoncol.2021.7239

## Connected records

- collections: [ClinicalTrials.gov](https://onco.cc/collections/clinicaltrials-gov/)
- ideas: [Registered reports for cancer biology: the plan is peer-reviewed before the result](https://onco.cc/ideas/idea-tr2-preclinical-registered-reports/)
- bottlenecks: [Biomarkers are not validated or standardised](https://onco.cc/bottlenecks/b-biomarker-validation/), [Preclinical results do not reproduce](https://onco.cc/bottlenecks/b-reproducibility/)
- key papers: [Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue](https://onco.cc/key-papers/paper-fernandez-jama-oncol/)
- roadmaps: [Diagnostics roadmap: stains → gene panels → blood tests that decide treatment](https://onco.cc/roadmaps/diagnostics-roadmap/)

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