# OnCo record external-control-arm (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/external-control-arm/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "external-control-arm" ;
  schema:name "External and synthetic control arms"@en ;
  schema:alternateName "external control"@en, "external control arm"@en, "external comparator"@en, "synthetic control"@en, "synthetic control arm"@en, "historical control"@en, "historical controls"@en, "historical comparison"@en, "real-world comparator"@en, "real-world control"@en, "natural history control"@en, "matched cohort"@en, "propensity-matched"@en, "propensity score"@en, "Bayesian borrowing"@en, "dynamic borrowing"@en, "hybrid control"@en, "external control arms"@en, "external controls"@en, "synthetic controls"@en ;
  schema:description "Instead of randomising patients to a control group, comparing a single-arm trial against patients treated in the past or recorded in registries, matched by propensity scores. Regulators accepted this for eflornithine in neuroblastoma and other rare cancers, but unmeasured differences between the groups, including changes in supportive care between eras, can masquerade as drug effects."@en ;
  schema:url <https://onco.cc/terms/external-control-arm/> ;
  schema:dateModified "2026-09-09"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Synthetic_control_method> ;
  schema:citation <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-design-and-conduct-externally-controlled-trials-drug-and-biological-products> ;
  onco:related <https://onco.cc/terms/single-arm/>, <https://onco.cc/terms/real-world-evidence/>, <https://onco.cc/terms/control-arm/>, <https://onco.cc/terms/accelerated-approval/>, <https://onco.cc/terms/bayesian-trial-design/>, <https://onco.cc/terms/trial-failure-modes/>, <https://onco.cc/terms/registry-based-trial/> ;
  onco:sections <https://onco.cc/fronts/drug-discovery/> ;
  onco:technologies <https://onco.cc/technologies/oncology-real-world-data/>, <https://onco.cc/companies/flatiron-health/> ;
  onco:trials <https://onco.cc/trials/nmtrc003/>, <https://onco.cc/trials/l-mind/>, <https://onco.cc/trials/act-iv/>, <https://onco.cc/trials/convert/> .