# Registry-based randomised trials for oncology comparative effectiveness

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

## TL;DR

Use the cancer registry itself as the trial machine: randomise patients at diagnosis, then let the registry collect the outcomes for a fraction of the usual cost.

## Summary

Registry-based randomised trials (R-RCTs), pioneered in Swedish cardiology, use the registry for identification, randomisation and outcome follow-up. Oncology has the registries (Nordic, England, Netherlands) but almost no R-RCTs. The proposal funds a programme of five R-RCTs on high-value comparative questions with routine endpoints (surveillance intervals, adjuvant duration, supportive care) and develops the ethics and consent templates to make the design routine.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: R-RCTs will answer comparative effectiveness questions with 2,000 or more patients at under 500 dollars per patient and within three years, roughly a tenth of conventional trial cost.
- Rationale: TASTE randomised 7,244 patients for a small fraction of a conventional trial budget; oncology questions about duration, schedule and surveillance have equally routine endpoints.
- Proposed test: Run one R-RCT in a Nordic or English registry (for example, imaging surveillance every six versus twelve months after curative colorectal surgery) and report cost, enrolment and completeness of outcomes.
- 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

- fronts: [AI & Computation](https://onco.cc/fronts/ai-computation/)
- institutions: [Karolinska University Hospital](https://onco.cc/institutions/karolinska/)
- terms: [Real-world evidence](https://onco.cc/terms/real-world-evidence/)
- bottlenecks: [Trial design, endpoints and cost](https://onco.cc/bottlenecks/b-trial-design/), [Trials enrol too few, too slowly](https://onco.cc/bottlenecks/b-trial-enrolment/), [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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