# OnCo record idea-data-accelerated-approval-registry-condition (idea). 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/ideas/idea-data-accelerated-approval-registry-condition/>
  a schema:CreativeWork ;
  onco:kind "idea" ;
  schema:identifier "idea-data-accelerated-approval-registry-condition" ;
  schema:name "Every patient on an accelerated-approval drug enrolled in a registry until confirmation"@en ;
  schema:description "Accelerated approvals rest on surrogate endpoints, and confirmatory trials take years and are sometimes never completed. Making registry enrolment with automatic outcome capture a condition of prescribing under accelerated approval would give regulators a real-world signal on benefit and toxicity within about two years, while the confirmatory trial runs."@en ;
  schema:url <https://onco.cc/ideas/idea-data-accelerated-approval-registry-condition/> ;
  schema:dateModified "2026-09-08"^^xsd:date ;
  schema:citation <https://doi.org/10.1001/jamainternmed.2019.0462> ;
  onco:sections <https://onco.cc/fronts/ai-computation/> ;
  onco:terms <https://onco.cc/terms/accelerated-approval/>, <https://onco.cc/terms/real-world-evidence/>, <https://onco.cc/terms/os/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-real-world-evidence/>, <https://onco.cc/bottlenecks/b-regulatory-fragmentation/> ;
  onco:keyPapers <https://onco.cc/key-papers/paper-gyawali-jama-intern-med/> .