# Shared concurrent control arms across sponsors' trials in the same setting

Source: https://onco.cc/ideas/idea-tr2-shared-control-network/  
OnCo record `idea-tr2-shared-control-network` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed 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

## Sources

- FDA complex innovative trial design programme: https://www.fda.gov/drugs/development-resources/complex-innovative-trial-design-meeting-program

## Connected records

- collections: [ClinicalTrials.gov](https://onco.cc/collections/clinicaltrials-gov/)
- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- terms: [Basket, umbrella, and platform trials](https://onco.cc/terms/basket-umbrella-platform/), [Hazard ratio (HR)](https://onco.cc/terms/hazard-ratio/)
- bottlenecks: [Too many combinations to test](https://onco.cc/bottlenecks/b-combination-space/), [Trials enrol too few, too slowly](https://onco.cc/bottlenecks/b-trial-enrolment/)

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