ideasIdea
Pre-registration and results reporting for real-world cancer studies
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.
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.
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.
What would test it
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
Who has to act
policy
Cost to try
Small (under $1M)
Years to first evidence
2
Bottlenecks it attacks
- Weak real-world evidence and registries · We do not reliably know what happens to patients after approval, so we cannot tell which drugs deliver in practice.
- Failures are hidden · Negative trials, failed drugs and abandoned programmes are rarely published, so the same mistakes are repeated.
- Preclinical results do not reproduce · Fewer than half of landmark cancer biology findings reproduce when someone else tries.