Public Pressure to Enforce Final Rule TranspariMED UAEM Compliance with legal requirement to report clinical trial results on ClinicalTrialsgov a cohort study Devito NJ Bacon S Goldacre ID: 1048291
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1. ClinicalTrials.gov update
2. Public Pressure to Enforce Final RuleTranspariMED/UAEMCompliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort studyDevito NJ, Bacon S, Goldacre B: January 17, 2020UAEM: Universities Allied for Essential MedicinesNew report: 25 major U.S. medical universities violate key transparency law. https://www.transparimed.org/single-post/2019/03/25/New-report-25-leading-US-universities-violate-key-medical-transparency-lawhttps://www.sciencemag.org/news/2020/01/fda-and-nih-let-clinical-trial-sponsors-keep-results-secret-and-break-lawLancetScienceOnly 2686/4209 (63.8%) reported resultsOnly 1722/4209 (40.9%) reported results on timeIndustry (50.3%)Non-Industry (33.8%)US Government (31.4%)
3. FDAAA TrialsTrackerhttp://fdaaa.trialstracker.net/
4. Notice of Noncompliance Issued to Acceleron Pharma, April 27th: https://www.fda.gov/media/148036/downloadFDA Statement, April 28: https://www.fda.gov/news-events/press-announcements/fda-takes-action-failure-submit-required-clinical-trial-results-information-clinicaltrialsgov
5. FDAAA 801 Violations field
6. FDAAA 801 Violations fieldThe FDAAA 801 Violation field identifies when FDA has issued a Notice of Noncompliance to the responsible party of an applicable clinical trial. A Notice of Noncompliance indicates that the FDA has determined the responsible party was not in compliance with the registration or results reporting requirements for the clinical trial under the Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801).Applies to Applicable Clinical TrialsThe National Library of Medicine (NLM) is required by FDAAA 801 to add information to a study record about any FDAAA 801 Violation. There are three categories of information that may be included:Failure to submit required clinical trial informationSubmission of false or misleading clinical trial informationFailure to submit primary and secondary outcomesNotice is sent to the Responsible Party (PI) identified in the ClinicalTrials.gov record (snail mail)Pre-Notice Letters are not identified as an FDAAA 801 Violation
7. UR Records Management ProcessProblem records:Each month, PI and record owner are emailed instructions to correct problemAfter two emails, there is a warning that the dept chair will be involvedEscalate to SADCR if neededResults reporting:PI and record owner are emailed at least 4 times during the 12 months before results are dues Need to communicate to current PIs if they get a letter from FDA to contact ResearchHelp@urmc.Rochester.edu