# OnCo record b-trial-design (bottleneck). 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/bottlenecks/b-trial-design/>
  a schema:Thing ;
  onco:kind "bottleneck" ;
  schema:identifier "b-trial-design" ;
  schema:name "Trial design, endpoints and cost"@en ;
  schema:description "A phase 3 trial takes years and hundreds of millions of dollars, and often answers a question that has already moved on."@en ;
  schema:url <https://onco.cc/bottlenecks/b-trial-design/> ;
  schema:dateModified "2026-09-08"^^xsd:date ;
  schema:citation <https://doi.org/10.1136/bmj.j4530>, <https://doi.org/10.1001/jamainternmed.2015.2829>, <https://www.fda.gov/about-fda/oncology-center-excellence/project-frontrunner>, <https://doi.org/10.1001/jama.2020.1166> ;
  onco:related <https://onco.cc/collections/fda-approvals/>, <https://onco.cc/collections/esmo-guidelines/>, <https://onco.cc/collections/clinicaltrials-gov/>, <https://onco.cc/ideas/idea-mrd-guided-stop-myeloma/>, <https://onco.cc/ideas/idea-tr1-external-control-rulebook/>, <https://onco.cc/ideas/idea-tr1-bayesian-borrowing-smaller-controls/>, <https://onco.cc/ideas/idea-tr1-seamless-2-3-with-prespecified-go/>, <https://onco.cc/ideas/idea-tr1-standing-platform-per-cancer/>, <https://onco.cc/ideas/idea-tr1-crossover-adjusted-survival-standard/>, <https://onco.cc/ideas/idea-tr1-ttf-and-qol-coprimary/>, <https://onco.cc/ideas/idea-tr1-public-de-escalation-trial-fund/>, <https://onco.cc/ideas/idea-tr1-immunotherapy-stop-trials/>, <https://onco.cc/ideas/idea-tr1-ctdna-guided-stop-in-metastatic-disease/>, <https://onco.cc/ideas/idea-tr1-mams-for-sequencing-questions/>, <https://onco.cc/ideas/idea-tr1-post-approval-pragmatic-trial-in-excluded/>, <https://onco.cc/ideas/idea-tr1-shared-control-arms-across-sponsors/>, <https://onco.cc/ideas/idea-tr1-tolerability-estimands/>, <https://onco.cc/ideas/idea-tr1-registry-linked-os-followup/>, <https://onco.cc/ideas/idea-tr1-shrinkage-subgroup-analysis/>, <https://onco.cc/ideas/idea-tr1-ai-central-imaging-reads/>, <https://onco.cc/ideas/idea-tr1-public-trial-cost-benchmarks/>, <https://onco.cc/ideas/idea-tr1-esource-ehr-to-edc/>, <https://onco.cc/ideas/idea-tr1-aggregated-n-of-1-supportive-care/>, <https://onco.cc/ideas/idea-tr1-aggressive-futility-boundaries/>, <https://onco.cc/ideas/idea-tr1-window-of-opportunity-default/>, <https://onco.cc/ideas/idea-tr1-randomised-phase-2-before-phase-3/>, <https://onco.cc/ideas/idea-tr1-smart-designs-for-adaptive-strategies/>, <https://onco.cc/ideas/idea-tr1-target-trial-emulation-to-prioritise-rcts/>, <https://onco.cc/ideas/idea-tr1-tumour-agnostic-approval-standard/>, <https://onco.cc/ideas/idea-tr1-open-protocol-and-sap-library/>, <https://onco.cc/ideas/idea-tr1-validate-real-world-progression-endpoints/> ;
  onco:cancers <https://onco.cc/cancers/prostate/>, <https://onco.cc/cancers/multiple-myeloma/>, <https://onco.cc/cancers/breast-hr-positive/> ;
  onco:technologies <https://onco.cc/technologies/mrd-testing/>, <https://onco.cc/technologies/ai-trial-matching/> ;
  onco:institutions <https://onco.cc/institutions/esmo/>, <https://onco.cc/institutions/asco/>, <https://onco.cc/institutions/nci/> ;
  onco:terms <https://onco.cc/terms/pfs/>, <https://onco.cc/terms/os/>, <https://onco.cc/terms/orr/>, <https://onco.cc/terms/hazard-ratio/>, <https://onco.cc/terms/accelerated-approval/>, <https://onco.cc/terms/basket-umbrella-platform/>, <https://onco.cc/terms/real-world-evidence/>, <https://onco.cc/terms/mrd-negativity-myeloma/>, <https://onco.cc/terms/pcr/>, <https://onco.cc/terms/efs/>, <https://onco.cc/terms/project-frontrunner/> ;
  onco:trials <https://onco.cc/trials/stampede/>, <https://onco.cc/trials/myelomatch/> ;
  onco:keyPapers <https://onco.cc/key-papers/paper-davis-bmj/>, <https://onco.cc/key-papers/paper-wouters-jama/> .