Biomarkers and benefits: avoiding the logical leap
The observation, its possible interpretation and the clinical claim should remain distinguishable.
Write three sentences before sharing a conclusion.
The observation, its possible interpretation and the clinical claim should remain distinguishable.
Separate the sentences
First sentence: “this change was measured.” Second: “this explanation is proposed.” Third: “this outcome was assessed in people.” If there was no clinical study, leave the third incomplete. This original organization helps identify where a summary adds information the study does not contain.
Validate for a use
The BEST resource distinguishes analytical and clinical validation and relates them to a specified use. Technical reliability does not turn a measurement into a substitute for every benefit. Ask which use was validated, in what context and with what evidence. State explicitly when that information is unavailable.
Professional context / Contexto profesional
Do not equate association, pharmacodynamic response and validation as a surrogate endpoint.
Evidence / Evidencia
Original editorial tool and FDA-NIH terminology.
Limitations / Limitaciones
Not a validated quality classification or a diagnostic algorithm.