Actually fine sponsors who do not post trial results
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.
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.
- Failures are hidden · Negative trials, failed drugs and abandoned programmes are rarely published, so the same mistakes are repeated.
Pages like this
not linked directly; found by shared links- IdeaPublish why patients were screened out of each trial
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov.
- IdeaOne clinical trial application accepted by regulators in every major region
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov.
- IdeaOne ethics approval and one consent form for a platform trial across countries
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov.
- IdeaPay investigators for finishing and publishing trials, not for enrolling patients
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov, Failures are hidden.
- IdeaOne national master contract and budget template for all cancer trials
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov.
- IdeaStop failing trials earlier with pre-registered aggressive futility rules
Shares ClinicalTrials.gov, Failures are hidden.
- IdeaA plain-language summary of every cancer trial result within a year
Shares EU Clinical Trials Register / CTIS, ClinicalTrials.gov.
- IdeaAutomatically detect when a trial changes its outcomes after the fact
Shares ClinicalTrials.gov, Failures are hidden.