# OnCo record confirmatory-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/confirmatory-trial/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "confirmatory-trial" ;
  schema:name "Confirmatory trial"@en ;
  schema:alternateName "confirmatory"@en, "confirmatory study"@en, "confirmatory phase 3"@en, "confirmatory evidence"@en, "post-marketing requirement"@en, "postmarketing requirement"@en, "post-approval trial"@en, "verify clinical benefit"@en, "conversion to full approval"@en, "dangling approval"@en, "dangling accelerated approval"@en, "confirmatory studies"@en, "post-marketing requirements"@en ;
  schema:description "The randomised trial a company must run after an accelerated approval to prove the drug really helps patients live longer or better. If it fails or never finishes, the approval is supposed to be withdrawn."@en ;
  schema:url <https://onco.cc/terms/confirmatory-trial/> ;
  schema:dateModified "2026-09-09"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Accelerated_approval_(FDA)> ;
  schema:citation <https://en.wikipedia.org/wiki/Accelerated_approval_(FDA)> ;
  onco:related <https://onco.cc/terms/accelerated-approval/>, <https://onco.cc/terms/full-approval/>, <https://onco.cc/terms/approval-withdrawal/>, <https://onco.cc/terms/surrogate-endpoint/>, <https://onco.cc/terms/complete-response-letter/>, <https://onco.cc/terms/surrogate-validation/>, <https://onco.cc/terms/trial-lifecycle/>, <https://onco.cc/terms/trial-failure-modes/> ;
  onco:sections <https://onco.cc/fronts/drug-discovery/> ;
  onco:trials <https://onco.cc/trials/announce/>, <https://onco.cc/trials/atlantis/>, <https://onco.cc/trials/keynote-522/> .