{"entity":{"id":"idea-tr2-fdaaa-enforcement","kind":"idea","name":"Actually fine sponsors who do not post trial results","aka":[],"tldr":"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.","asOf":"2026-09-08","links":[{"label":"FDAAA TrialsTracker","url":"https://fdaaa.trialstracker.net/"}],"tags":[],"related":["clinicaltrials-gov","eudract-ctis"],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-negative-results"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"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.","test":"Implement and publish the enforcement policy; track monthly compliance rates against the pre-policy baseline.","maturity":"early-clinical","actor":"regulator","cost":"small","horizonYears":1},"route":"/ideas/idea-tr2-fdaaa-enforcement/","neighbours":{"collection":[{"id":"clinicaltrials-gov","kind":"collection","name":"ClinicalTrials.gov","route":"/collections/clinicaltrials-gov/"},{"id":"eudract-ctis","kind":"collection","name":"EU Clinical Trials Register / CTIS","route":"/collections/eudract-ctis/"}],"bottleneck":[{"id":"b-negative-results","kind":"bottleneck","name":"Failures are hidden","route":"/bottlenecks/b-negative-results/"}],"idea":[{"id":"idea-tr2-sponsor-transparency-score","kind":"idea","name":"A public transparency score for every trial sponsor, used by sites and patients","route":"/ideas/idea-tr2-sponsor-transparency-score/"},{"id":"idea-tr2-irb-results-gate","kind":"idea","name":"No new trial approval until the sponsor has reported its old ones","route":"/ideas/idea-tr2-irb-results-gate/"}]}}