# OnCo record pivotal-trial (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/pivotal-trial/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "pivotal-trial" ;
  schema:name "Pivotal (registrational) trial"@en ;
  schema:alternateName "pivotal"@en, "pivotal trial"@en, "pivotal study"@en, "pivotal phase 3"@en, "registrational"@en, "registrational trial"@en, "registrational study"@en, "registration trial"@en, "registration-enabling"@en, "registration-directed"@en, "approval-enabling"@en, "pivotal cohort"@en, "registrational cohort"@en, "supported approval"@en, "basis of approval"@en, "approval was based on"@en, "registration trials"@en, "registrational trials"@en ;
  schema:description "The trial (usually a randomised phase 3, sometimes a large phase 2) whose results are submitted to regulators as the main evidence for approval. When a company calls a trial 'registrational' it is signalling that this is the one that decides."@en ;
  schema:url <https://onco.cc/terms/pivotal-trial/> ;
  schema:dateModified "2026-09-09"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Phases_of_clinical_research> ;
  schema:citation <https://en.wikipedia.org/wiki/Phases_of_clinical_research> ;
  onco:related <https://onco.cc/terms/primary-endpoint/>, <https://onco.cc/terms/bla-nda/>, <https://onco.cc/terms/single-arm/>, <https://onco.cc/terms/confirmatory-trial/>, <https://onco.cc/terms/trial-lifecycle/>, <https://onco.cc/terms/trial-registration/>, <https://onco.cc/terms/group-sequential-design/> ;
  onco:sections <https://onco.cc/fronts/drug-discovery/> ;
  onco:trials <https://onco.cc/trials/keynote-522/>, <https://onco.cc/trials/adaura/>, <https://onco.cc/trials/navigate/> .