ideasIdea
Label every biomarker claim with an evidence phase, like drugs
Drugs are described as phase 1, 2 or 3 so everyone knows how proven they are. Biomarkers should carry the same kind of label so a 'promising' marker is not mistaken for a validated one.
Biomarker development stages exist in the literature (discovery, analytical validation, clinical validation, clinical utility, as in the Early Detection Research Network's five phases) but are not applied to published claims or guideline statements. A simple grading (B1 discovery, B2 analytically validated, B3 clinically validated retrospectively, B4 prospectively validated, B5 utility shown in a randomised trial) attached to biomarker entries in guidelines, knowledge bases and papers would make the evidence gap visible.
Hypothesis
After adoption, the proportion of guideline-recommended biomarkers at B4 or above will be reported and will rise year on year, and clinicians will rate biomarker evidence more accurately in surveys.
Rationale
Evidence grading (GRADE, levels of evidence) improved clarity for treatments; biomarkers lack any equivalent that patients and clinicians see.
What would test it
Grade all biomarkers in two guideline sets and one knowledge base; survey clinicians before and after on their perception of validation status.
Maturity
speculative
Who has to act
research
Cost to try
Small (under $1M)
Years to first evidence
2
Bottlenecks it attacks
- Biomarkers are not validated or standardised · Tests that decide who gets a drug are often not validated prospectively and are measured differently in every lab.
- Knowledge reaches practice too slowly · Knowledge diffusion is slow: it takes years for a proven result to change what most patients receive, and no one can keep up with the literature.