# OnCo record idea-tr1-external-control-rulebook (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-tr1-external-control-rulebook/>
  a schema:CreativeWork ;
  onco:kind "idea" ;
  schema:identifier "idea-tr1-external-control-rulebook" ;
  schema:name "A public rulebook for when an external or synthetic control arm is acceptable"@en ;
  schema:description "Sometimes a trial cannot randomise, so the new drug is compared with past patients' records. Clear published rules on when that is allowed, and how it must be done, would replace case-by-case guesswork."@en ;
  schema:url <https://onco.cc/ideas/idea-tr1-external-control-rulebook/> ;
  schema:dateModified "2026-09-08"^^xsd:date ;
  schema:citation <https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence> ;
  onco:terms <https://onco.cc/terms/real-world-evidence/>, <https://onco.cc/terms/accelerated-approval/>, <https://onco.cc/terms/hazard-ratio/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-trial-design/>, <https://onco.cc/bottlenecks/b-real-world-evidence/>, <https://onco.cc/bottlenecks/b-rare-cancers/> .