# A pre-registered standard for emulating trials with real-world data

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

## TL;DR

When researchers use hospital records to ask 'would drug A have beaten drug B in a trial', they should follow a published recipe and register their plan first, so the answer can be trusted.

## Summary

Target trial emulation (specifying the hypothetical randomised trial, then mimicking it in observational data) is the accepted framework for causal inference from real-world data, but the rigour of oncology emulations is inconsistent. The proposal is a formal standard: a protocol template (eligibility, treatment strategies, assignment, time zero, outcomes, causal contrast, analysis plan), mandatory pre-registration, and a requirement to report a positive control emulation of a known RCT in the same dataset, adopted by regulators and journals as a condition of considering RWE.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Emulations that follow the standard and pass a positive-control calibration will agree with subsequent randomised trials on the direction of effect in more than 85 percent of cases, versus roughly 60 percent for unstandardised observational oncology studies.
- Rationale: The RCT-DUPLICATE project showed that carefully designed emulations can reproduce RCT results when design elements are matched; the failures came from avoidable design flaws such as immortal time bias. A standard forces the fixes.
- Proposed test: Apply the standard prospectively to ten oncology questions with ongoing RCTs; lock the emulation results before the trials read out; compare.
- Maturity: early-clinical
- Actor: regulator

## Sources

- RCT-DUPLICATE: https://www.rctduplicate.org/

## Connected records

- fronts: [AI & Computation](https://onco.cc/fronts/ai-computation/)
- terms: [Hazard ratio (HR)](https://onco.cc/terms/hazard-ratio/), [Real-world evidence](https://onco.cc/terms/real-world-evidence/)
- bottlenecks: [Trial design, endpoints and cost](https://onco.cc/bottlenecks/b-trial-design/), [Weak real-world evidence and registries](https://onco.cc/bottlenecks/b-real-world-evidence/)
- ideas: [An open library pairing completed cancer trials with real-world emulations](https://onco.cc/ideas/idea-data-rwe-rct-calibration-library/)

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