# OnCo record biomarker-stratified-design (term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/terms/biomarker-stratified-design/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "biomarker-stratified-design" ;
  schema:name "Enrichment and biomarker-stratified designs"@en ;
  schema:alternateName "enrichment design"@en, "enrichment designs"@en, "enriched population"@en, "biomarker-enrichment"@en, "biomarker-positive only"@en, "biomarker-stratified"@en, "biomarker-stratified design"@en, "biomarker-stratified trial"@en, "marker-stratified"@en, "marker-by-treatment interaction"@en, "interaction test"@en, "predictive biomarker"@en, "prognostic versus predictive"@en, "prognostic biomarker"@en, "biomarker-negative"@en, "biomarker negative"@en, "marker-negative"@en, "all-comers design"@en, "all-comers trial"@en, "co-development of drug and test"@en, "companion diagnostic trial"@en, "separate cohorts"@en, "parallel cohorts"@en ;
  schema:description "An enrichment design enrols only patients whose tumours carry the marker the drug needs; a stratified design enrols everyone but tests marker-positive and marker-negative patients separately, to learn whether the marker predicts benefit."@en ;
  schema:url <https://onco.cc/terms/biomarker-stratified-design/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:citation <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enrichment-strategies-clinical-trials-support-approval-human-drugs-and-biological-products>, <https://www.ich.org/page/efficacy-guidelines> ;
  onco:related <https://onco.cc/terms/biomarker/>, <https://onco.cc/terms/seamless-adaptive/>, <https://onco.cc/terms/stratified-randomisation/>, <https://onco.cc/terms/subgroup-analysis/>, <https://onco.cc/terms/basket-trial/>, <https://onco.cc/terms/umbrella-trial/>, <https://onco.cc/terms/prespecified-vs-post-hoc/>, <https://onco.cc/terms/trial-failure-modes/>, <https://onco.cc/terms/ctdna/> ;
  onco:sections <https://onco.cc/fronts/drug-discovery/> ;
  onco:drugs <https://onco.cc/drugs/niraparib/>, <https://onco.cc/drugs/oncotype-dx/>, <https://onco.cc/drugs/mammaprint/>, <https://onco.cc/drugs/signatera/> ;
  onco:trials <https://onco.cc/trials/magnitude/>, <https://onco.cc/trials/tailorx/>, <https://onco.cc/trials/mindact/>, <https://onco.cc/trials/rxponder/>, <https://onco.cc/trials/imvigor011/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-trial-design/> .