{"entity":{"id":"analytical-vs-clinical-validation","kind":"term","name":"Analytical versus clinical validation","aka":["analytical validation","clinical validation","analytical validity","clinical validity","clinical utility","validation of a biomarker test"],"tldr":"Analytical validation shows a test measures what it claims, reliably; clinical validation shows the measurement actually predicts the patient outcome it is meant to.","summary":"A biomarker in medicine is a measurable indicator of the presence or severity of a disease state (Wikipedia). Before it is used, a test must show analytical validity (accuracy, precision, reproducibility of the measurement itself) and clinical validity (that the result relates to the clinical condition or outcome in the intended population), and ideally clinical utility, that acting on it improves outcomes. For an AI model the same ladder applies: reproducible outputs on fixed inputs, then discrimination and calibration on external cohorts, then a trial of using it.","asOf":"2026-09-24","wikipedia":"https://en.wikipedia.org/wiki/Biomarker_(medicine)","links":[{"label":"FDA: Software as a Medical Device (SaMD)","url":"https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd"},{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Biomarker_(medicine)"}],"tags":["cansim-terms"],"related":["cancer-ai-vocabulary"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["external-validation","calibration","samd","biomarker"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Listed in the CanSim terms map 1.0.0 (docs/onco/terms.json, generated 2026-09-24), CC BY 4.0, attribution: CanSim project, an open, public-data-first cancer foundation-model programme; CanSim page path /terms/clinical-vs-analytical-validation."],"provenance":{"editedBy":"OnCo CanSim terms wave (Wikipedia summaries, standards and project pages, GDC and FDA pages, Europe PMC)","editedOn":"2026-09-24","note":"CanSim terms map 1.0.0 (docs/onco/terms.json, generated 2026-09-24), CC BY 4.0, attribution: CanSim project, an open, public-data-first cancer foundation-model programme"},"category":"Biomarkers"},"route":"/terms/analytical-vs-clinical-validation/","neighbours":{"term":[{"id":"biomarker","kind":"term","name":"Biomarker","route":"/terms/biomarker/"},{"id":"calibration","kind":"term","name":"Calibration: reliability diagrams and the Brier score","route":"/terms/calibration/"},{"id":"cancer-ai-vocabulary","kind":"term","name":"Cancer AI vocabulary (CanSim terms map)","route":"/terms/cancer-ai-vocabulary/"},{"id":"external-validation","kind":"term","name":"External validation","route":"/terms/external-validation/"},{"id":"research-use-only","kind":"term","name":"Research use only (RUO)","route":"/terms/research-use-only/"},{"id":"samd","kind":"term","name":"Software as a medical device (SaMD)","route":"/terms/samd/"}]}}