New Automated Tool Monitors Clinical Trial Reporting

The watchdog website FDAAA TrialsTracker names and shames human studies that breach the FDA’s requirements for reporting results.

Written byDiana Kwon

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The FDAAA TrialsTracker, an automated online watchdog that provides daily updates of clinical trials that are noncompliant with legal reporting requirements in the U.S., debuted this week (February 19).

This is the second instalment of TrialsTracker, which was unveiled by researchers at the University of Oxford’s Evidence-Based Medicine (EBM) DataLab in 2016. That site monitored all clinical trials registered on clinicaltrials.gov. The new version follows only those studies required to be reported by the FDA Amendments Act (FDAAA), under which investigators are to file the results of certain clinical trials, such as those involving drugs and devices, on clinicaltrials.gov within 12 months of completion. Although the law initially came into effect in 2007, the Final Rule in 2016 expanded and clarified its requirements.

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Meet the Author

Diana Kwon
Diana is a freelance science journalist who covers the life sciences, health, and academic life. She’s a regular contributor to The Scientist and her work has appeared in several other publications, including Scientific American, Knowable, and Quanta. Diana was a former intern at The Scientist and she holds a master’s degree in neuroscience from McGill University. She’s currently based in Berlin, Germany.
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