# An open library pairing completed cancer trials with real-world emulations

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

## TL;DR

Build a public library in which every phase 3 cancer trial is paired with a real-world emulation in federated hospital data, publishing how far the two agree in direction, magnitude and confidence interval overlap. Oncology needs its own calibration set because RCT-DUPLICATE covered mostly cardiometabolic disease, and it would map which question types can be trusted.

## Summary

RCT-DUPLICATE calibrated real-world methods against trials mostly in cardiometabolic disease; oncology, with its time-varying treatments and surrogate endpoints, needs its own calibration set. The proposal funds a standing programme that emulates every phase 3 oncology trial with a real-world counterpart in federated data, publishes agreement metrics (direction, magnitude, confidence interval overlap), and maintains a public map of which question types (first-line comparisons, sequencing, dose) are emulable.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Across 100 oncology trials, emulation agreement will be high for first-line drug-versus-drug comparisons with hard endpoints and poor for questions involving progression-based endpoints or treatment switching, giving regulators an evidence-based rule for when RWE can substitute for a trial.
- Rationale: Without a calibration library, every RWE submission is argued case by case. A map of emulability converts the debate into a lookup table.
- Proposed test: Fund the first 30 emulations across breast, lung and prostate; publish agreement metrics; test whether the resulting rule predicts agreement in the next 20.
- Maturity: early-clinical
- Actor: research

## 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

- ideas: [A pre-registered standard for emulating trials with real-world data](https://onco.cc/ideas/idea-data-target-trial-emulation-standard/)
- fronts: [AI & Computation](https://onco.cc/fronts/ai-computation/)
- terms: [Real-world evidence](https://onco.cc/terms/real-world-evidence/)
- bottlenecks: [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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