The TrialsTracker team has launched a new tool, aimed at monitoring compliance with the FDA Amendments Act (FDAAA) 2007. The FDAAA, and the ‘Final Rule’, which clarified and expanded on the Act, require clinical trials of FDA-regulated products to report results within 12 months of trial completion. The Final Rule came into effect on 18 January 2017, therefore the results of the first clinical trials covered by the requirements are now due.
TrialsTracker, which campaigns for the open publication of all clinical trial data, hopes that their new tool ‘FDAAA TrialsTracker’ will highlight any studies that fail to comply with the FDAAA. The automated tool uses coding technologies to identify clinical trials registered on ClinicalTrials.gov that are required under the FDAAA to publicly report trial data, as well as the date by which each trial is due to publish these data. The tool then tracks and publishes adherence levels. The group plans to alert the FDA on a weekly basis to any studies failing to meet these requirements. Their hope is that the tracker will contribute to the continued improvement of trial reporting and data transparency. At the time of writing, the tracker calculates that the results of 89% of eligible clinical trials have been reported.