The FDAAA TrialsTracker: Live and Public Information on Unreported Clinical Trial Results
Jun 10, 2021https://fdaaa.trialstracker.net is an online searchable tool developed by the Evidence Based Medicine DataLab at the University of Oxford. It publicly monitors compliance with the FDA Amendments Act of 2007 (“FDAAA”), which requires that Applicable Clinical Trials (ACTs) must report basic results within 12 months of the last visit by a study subject where data was collected for a primary study outcome.
The intent of the TrialsTracker is to increase accountability for disseminating the results of clinical trials. More information about the tracker and the problems it is intended to address is available in the developers’ paper on the project.
The tracker does not include studies which are not Applicable Clinical Trials, but which are required to report results under NIH policy (e.g. NIH, VA).
For help submitting results to ClinicalTrials.gov, please contact clinicalresearchsupportcenter@ucdenver.edu.