{"entity":{"id":"idea-tr2-shared-control-network","kind":"idea","name":"Shared concurrent control arms across sponsors' trials in the same setting","aka":[],"tldr":"When five companies each run a trial against the same standard treatment in the same patients, let them pool the standard-treatment patients so fewer people are randomised to the old drug.","summary":"Concurrent trials in the same indication each recruit their own control arm on identical standard of care. A pre-agreed common data model, shared eligibility core and a neutral data custodian would let sponsors borrow concurrent (not historical) controls with regulatory pre-agreement, as pioneered by the Alzheimer's Disease EPOCH and the Bayesian borrowing frameworks in paediatric oncology.","asOf":"2026-09-08","links":[{"label":"FDA complex innovative trial design programme","url":"https://www.fda.gov/drugs/development-resources/complex-innovative-trial-design-meeting-program"}],"tags":[],"related":["clinicaltrials-gov"],"cancers":["urothelial","pancreatic"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["basket-umbrella-platform","hazard-ratio"],"trials":[],"people":[],"bottlenecks":["b-combination-space","b-trial-enrolment"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"A shared-control network in first-line metastatic urothelial or pancreatic cancer reduces total patients randomised to control by at least 40% across participating trials without inflating type I error beyond pre-specified bounds.","rationale":"Concurrent controls avoid the drift and selection bias that make historical controls unreliable. FDA's complex innovative design programme and EMA have both accepted Bayesian borrowing when exchangeability is demonstrated.","test":"Pilot with three sponsors in one indication under FDA's complex innovative trial design meeting programme; simulate operating characteristics, then run and compare control-arm outcomes across sponsors for exchangeability.","maturity":"early-clinical","actor":"regulator","cost":"medium","horizonYears":4},"route":"/ideas/idea-tr2-shared-control-network/","neighbours":{"collection":[{"id":"clinicaltrials-gov","kind":"collection","name":"ClinicalTrials.gov","route":"/collections/clinicaltrials-gov/"}],"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"term":[{"id":"basket-umbrella-platform","kind":"term","name":"Basket, umbrella, and platform trials","route":"/terms/basket-umbrella-platform/"},{"id":"hazard-ratio","kind":"term","name":"Hazard ratio (HR)","route":"/terms/hazard-ratio/"}],"bottleneck":[{"id":"b-combination-space","kind":"bottleneck","name":"Too many combinations to test","route":"/bottlenecks/b-combination-space/"},{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"}]}}