Cohort study data from 2018 to 2019 suggest poor compliance with the US Food and Drug Administration (FDA) reporting requirements for clinical trial sponsors, according to results published in the Lancet. Although industry sponsors and sponsors running a larger number of trials were more likely to be compliant with reporting guidelines, just 41% of studied trials had results within 1 year of primary completion per the FDA guidelines.
The 2007 FDA Amendments Act (FDAAA) stipulates that sponsors of applicable clinical trials must report their results to ClinicalTrials.gov within 1 year of study completion. The “Final Rule” of the FDAAA, implemented in January 2017, provided clarification on which studies were required to report. To assess compliance with this newest iteration of the FDAAA, investigators conducted a cohort study of all applicable clinical trials due to report by January 2018. Studies were classified as applicable clinical trials if more than 1 year had passed since the primary completion date. Nonapplicable trials, trials not due to report, and trials that had received a certificate allowing delayed reporting were excluded. Raw data for applicable clinical trials were downloaded each month from March 2018 through September 2019. Applicable clinical trials were considered compliant if results had been submitted within 1 year of the primary completion date. Multivariable odds ratios (ORs) for compliance were constructed for various applicable clinical trial characteristics, including sponsor type and study location.
As of September 16, 2019, 4209 trials registered with ClinicalTrials.gov were due to report results. Of these, just 1722 (40.9%) were compliant with the 1-year deadline, whereas 2686 (63.8%) were delinquent. The median time from primary completion date to reporting date was 424 days (95% confidence interval [CI], 412-435 days). Industry sponsors were significantly more likely to report results (adjusted OR [aOR], 1.62; 95% CI, 1.35-1.96; P <.0001) and to comply with FDAAA requirements (aOR, 3.08; 95% CI, 2.52-3.77; P <.0001) than nonindustry, non-US government sponsors. The presence of an industry collaborator was also associated with increased odds of compliance (aOR, 1.30; 95% CI, 1.08-1.58; P =.0065). Sponsors with a large number (≥12) of registered trials in ClinicalTrials.gov also were more likely to report in compliance than sponsors with fewer trials. Sponsors in the greatest quartile of number of registered trials (925-3276 trials) had nearly 12-fold increased odds of compliance than sponsors with from 1 to 12 registered trials (aOR, 11.84; 95% CI, 9.36-14.99; P <.0001). Trials with sites both in the United States and in other countries were significantly more likely to be compliant than trials with only US sites, trials without US sites, and trials with no location data available.
Compliance with FDAAA reporting requirements has not appreciably improved since the passage of the Last Rule. Poor compliance is likely an artifact of insufficient reinforcement. As of November 2019, no fines have been imposed by the FDA to noncompliant sponsors. “In the absence of statutory enforcement, open public audit is…a valuable tool to increase accountability,” the authors wrote.
DeVito NJ, Bacon S, Goldacre B. Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study. Lancet. 2020;395(10221):361-369.