Clinical trial reporting: compliance with US rules is poor and not improving, study finds

Only 41% of clinical trials reported their results to the US clinical trials registry within a year of completion as required by law, a study has found. Researchers from Oxford University, UK, who identified 2497 clinical trials that had breached the rules, called for better enforcement from the US Food and Drug Administration.1

The FDA Amendments Act 2007 requires trial sponsors to report results directly to ClinicalTrials.gov within one year of completion, regardless of whether the results are positive or negative. The first trials covered by the final rule of this act came due to report results in January 2018.

The first comprehensive study of compliance since the new regulations came into effect found that, of the …