# Pre-registration and results reporting for real-world cancer studies

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

## TL;DR

Just as clinical trials must be registered before they start, studies using hospital data should be registered too, so the failed or unwelcome ones cannot quietly disappear.

## Summary

Real-world studies are prone to selective reporting and analytic flexibility; there is no registration requirement. The proposal creates a registry for observational oncology studies (protocol, analysis plan, data source, funder) with results deposition within 12 months, required by journals, regulators considering RWE, and funders. The EU PAS register and the RWE Transparency Initiative are partial precedents.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Mandatory registration will make more than 80 percent of published oncology RWE studies traceable to a pre-registered protocol within five years and will reduce the rate of positive-only reporting measurably.
- Rationale: Trial registration reduced outcome switching and publication bias; observational research has the same problems with fewer safeguards, and RWE is increasingly used in regulatory and payer decisions.
- Proposed test: Compare the proportion of pre-registered versus non-registered RWE studies reporting positive primary findings; pilot mandatory registration with two journals for one year.
- Maturity: speculative
- Actor: policy

## Sources

- EU PAS Register (HMA-EMA catalogue): https://catalogues.ema.europa.eu/

## Connected records

- fronts: [AI & Computation](https://onco.cc/fronts/ai-computation/)
- terms: [Real-world evidence](https://onco.cc/terms/real-world-evidence/)
- bottlenecks: [Failures are hidden](https://onco.cc/bottlenecks/b-negative-results/), [Preclinical results do not reproduce](https://onco.cc/bottlenecks/b-reproducibility/), [Weak real-world evidence and registries](https://onco.cc/bottlenecks/b-real-world-evidence/)

---
JSON: https://onco.cc/api/v1/entities/idea-data-observational-study-registration.json