Compliance with a federal law requiring sponsors of applicable clinical trials to report results within 1 year of trial completion is poor and not improving, investigators concluded.
The Final Rule of the Food and Drug Administration Amendments Act (FDAAA) of 2007 requires sponsors of applicable trials to report their results directly onto the ClinicalTrials.gov website within 1 year of completion. The first trials were due to report results in January 2018.
Of 4209 applicable trials due to report results, only 1722 (40.9%) did so within the 1-year deadline, whereas 2686 (63.8%) had submitted results at any time, the investigators reported.
“To our knowledge, this is the first study to assess compliance with the Final Rule of the FDAAA of 2007,” Nicholas J. DeVito, MPH, and colleagues at the University of Oxford in the United Kingdom reported in The Lancet. “This law was widely celebrated as a solution to the problems of publication bias and clinical trial reporting. Our findings raise important questions around lack of enforcement and the need for public accountability.”
For the trial, the investigators extracted data from ClinicalTrials.gov up to September 16, 2019. As of this date, the website’s database contained 316,342 trials. The investigators excluded 294,817 trials because they were neither an applicable clinical trial (ACT) nor a probable ACT under the Final Rule. They excluded an additional 16,650 trials because they were not yet due to report results and 666 trials that were due to report results but received a certificate of delay from ClinicalTrials.gov.
In addition, the study also found that industry sponsors had significant 3-fold increased odds of compliance than non-industry sponsors or non-US government sponsors. In addition, sponsors conducting large numbers of trials (887 to 3254 trials) had significant 12-odds increased of compliance than sponsors of smaller numbers of trials (1 to 12).
The median delay from primary completion data to submission date was 424 days—59 days more than the legal reporting requirement of 1 year.
“Poor compliance is likely to reflect lack of enforcement of regulators,” the authors concluded. “Effective enforcement and action from sponsors is needed; until then, open public audit of compliance for each individual sponsor may help.”
DeVito NJ, Bacon S, Goldacre B. Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study [published online January 17, 2020]. Lancet. 2020;395:361-369. doi: 10.1016/S0140-6736(19)33220-9