Compliance with legal requirement to report clinical trial results on ClinicalTrials
17 January 2020
| Failure to report the results of a clinical trial can distort the evidence base for clinical practice, breaches researchers’ ethical obligations to participants, and represents an important source of research waste. The Food and Drug Administration Amendments Act (FDAAA) of 2007 now requires sponsors of applicable trials to report their results directly onto ClinicalTrials.gov within 1 year of completion. The first trials covered by the Final Rule of this act became due to report results in January, 2018. In this cohort study, we set out to assess compliance. | |
| Compliance with the FDAAA 2007 is poor, and not improving. To our knowledge, this is the first study to fully assess compliance with the Final Rule of the FDAAA 2007. Poor compliance is likely to reflect lack of enforcement by regulators. Effective enforcement and action from sponsors is needed; until then, open public audit of compliance for each individual sponsor may help. We will maintain updated compliance data for each individual sponsor and trial at fdaaa.trialstracker.net. | |
| Author(s) | Source |
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DeVito NJ, Bacon S, Goldacre B
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The Lancet, Jan 17 2020, DOI:https://doi.org/10.1016/S0140-6736(19)33220-9 |
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