OnCo
ideasIdea

Pre-register biomarker validation studies the way trials are registered

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.

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.

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.
What would test it
Launch the registry with two journals requiring registration; compare reported effect sizes and replication rates over three years.
Maturity
speculative
Who has to act
policy
Cost to try
Small (under $1M)
Years to first evidence
2
Bottlenecks it attacks

Connected

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