# OnCo record idea-tr1-post-approval-pragmatic-trial-in-excluded (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-post-approval-pragmatic-trial-in-excluded/>
  a schema:CreativeWork ;
  onco:kind "idea" ;
  schema:identifier "idea-tr1-post-approval-pragmatic-trial-in-excluded" ;
  schema:name "After approval, a pragmatic trial in the patients the pivotal trial excluded"@en ;
  schema:description "Drugs are approved on trials of fit, younger patients and then given to everyone. A required follow-on trial in older, sicker and more diverse patients would show whether the benefit holds in real life."@en ;
  schema:url <https://onco.cc/ideas/idea-tr1-post-approval-pragmatic-trial-in-excluded/> ;
  schema:dateModified "2026-09-08"^^xsd:date ;
  schema:citation <https://www.fda.gov/about-fda/oncology-center-excellence/project-pragmatica>, <https://clinicaltrials.gov/study/NCT05633602> ;
  onco:institutions <https://onco.cc/institutions/nci/> ;
  onco:terms <https://onco.cc/terms/real-world-evidence/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-trial-design/>, <https://onco.cc/bottlenecks/b-real-world-evidence/>, <https://onco.cc/bottlenecks/b-aging-comorbidity/> .