Compliance with legal requirement to report clinical trial results on ClinicalTrials

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
DeVito NJ, Bacon S, Goldacre B
The Lancet, Jan 17 2020, DOI:https://doi.org/10.1016/S0140-6736(19)33220-9
This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register.
Comments: n/a
let us know

COVID-19
news

stay connected

don’t miss any news of the
Implant-Register,
tailored to your preferences

                                  GET IT!

Scroll to Top