# A global federated real-world evidence network at regulatory grade

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

## TL;DR

Connect hospital records across countries so that questions about how treatments work in real patients can be answered in weeks without moving the data, to a standard regulators accept.

## Summary

Real-world evidence is fragmented, of variable quality and rarely accepted for decisions beyond safety. Federated analytics (OHDSI, DARWIN EU, Flatiron-style curated networks) demonstrate feasibility. The proposal is a global federated oncology network: common data model with oncology extensions, automated quality scoring, pre-registered analysis protocols executed locally with only aggregates shared, external control arm generation for rare indications, and a regulatory framework specifying when network evidence can support label expansions, pricing revisions and post-approval commitments.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Network-generated evidence supports at least ten regulatory or reimbursement decisions in five years and reproduces trial results in emulation studies with high fidelity.
- Rationale: Trial emulation has shown real-world data can reproduce randomised results when design is rigorous; federation solves privacy and sovereignty and scale simultaneously.
- Proposed test: Run twenty pre-registered trial emulations across the network and compare with the trials; then submit external control evidence for a rare indication.
- Maturity: early-clinical
- Actor: data

## Sources

- Bottleneck evidence (Weak real-world evidence and registries): Gyawali, Hey & Kesselheim, Assessment of the clinical benefit of cancer drugs receiving accelerated approval (JAMA Intern Med 2019): https://doi.org/10.1001/jamainternmed.2019.0462

## Connected records

- companies: [Foundation Medicine (Roche)](https://onco.cc/companies/foundation-medicine/), [Tempus AI](https://onco.cc/companies/tempus/)
- terms: [Real-world evidence](https://onco.cc/terms/real-world-evidence/)
- bottlenecks: [Data silos](https://onco.cc/bottlenecks/b-data-silos/), [Weak real-world evidence and registries](https://onco.cc/bottlenecks/b-real-world-evidence/)
- key papers: [Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval](https://onco.cc/key-papers/paper-gyawali-jama-intern-med/)

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