Intended for healthcare professionals

Research News

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

BMJ 2020; 368 doi: (Published 18 January 2020) Cite this as: BMJ 2020;368:m217
  1. Jacqui Wise
  1. London

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 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 …

View Full Text

Log in

Log in through your institution


* For online subscription