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The FDAAA TrialsTracker is Live!
This week, we launched our FDAAA TrialsTracker which gives you a live look at whether individual sponsors and trialists are meeting their responsibility to report the results of clinical trials on ClinicalTrials.gov. A lot of work went into the tracker and making sure we got it right. You can read all about our methods, in detail, here but the short version goes like this…
Certain trials registered on ClinicalTrials.gov, the US trial registry run by the National Institutes of Health (NIH), are required to report their results. This requirement began with the passing of the FDA Amendment Act of 2007 (FDAAA) but different interpretations of the broad requirements laid down under FDAAA led to some confusion over who was required to report and when. In September of 2016, a “Final Rule” was published by the NIH that clarified and expanded how the reporting requirement under FDAAA would operate moving forward. The Final Rule came into effect on January 18, 2017.