# Actually fine sponsors who do not post trial results

Source: https://onco.cc/ideas/idea-tr2-fdaaa-enforcement/  
OnCo record `idea-tr2-fdaaa-enforcement` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

US law already requires trial results to be posted within a year and allows fines of over ten thousand dollars a day. Almost no fines have ever been issued. Start issuing them.

## Summary

FDAAA 801 requires results posting on ClinicalTrials.gov within twelve months of primary completion for applicable trials; compliance has hovered around 40 to 70% depending on sponsor type. Enforcement has been minimal. A published enforcement policy with automatic notices, escalating penalties and public listing of non-compliant sponsors, plus an equivalent under the EU Clinical Trials Regulation, would raise compliance.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Systematic enforcement raises on-time results posting for oncology trials above 90% within two years, as measured by the TrialsTracker methodology.
- Rationale: When the EU Clinical Trials Register began publicly listing non-compliance and universities faced reputational pressure, UK university compliance rose from under 50% to over 90% in about two years.
- Proposed test: Implement and publish the enforcement policy; track monthly compliance rates against the pre-policy baseline.
- Maturity: early-clinical
- Actor: regulator

## Sources

- FDAAA TrialsTracker: https://fdaaa.trialstracker.net/

## Connected records

- collections: [ClinicalTrials.gov](https://onco.cc/collections/clinicaltrials-gov/), [EU Clinical Trials Register / CTIS](https://onco.cc/collections/eudract-ctis/)
- bottlenecks: [Failures are hidden](https://onco.cc/bottlenecks/b-negative-results/)
- ideas: [A public transparency score for every trial sponsor, used by sites and patients](https://onco.cc/ideas/idea-tr2-sponsor-transparency-score/), [No new trial approval until the sponsor has reported its old ones](https://onco.cc/ideas/idea-tr2-irb-results-gate/)

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