The study published in The Lancet reported on the levels of compliance with the Food and Drug Administration Amendments Act 2007 (FDAAA 2007), which requires sponsors of applicable trials to report their results onto the ClinicalTrials.gov website within one year of completion.
To assess compliance with the act, researchers from the University of Oxford downloaded data from ClinicalTrials.gov. The dataset featured 4,209 clinical trials that were due to report results.
Researchers downloaded the relevant data from studies between March 2018 and September 2019, with the figures showing that 40.9% of trials had submitted their data prior to the deadline. Further than this, 63.8% of trials had submitted trial results at any time.
The analysis reported that non-industry, non-US government sponsors, and sponsors running large numbers of trials, were more likely to be compliant compared with small sponsors.
The compliance rate among industry sponsors masks variation between companies of different sizes. Compliance at AstraZeneca, Gilead Sciences, GlaxoSmithKline, Novartis, Pfizer and Roche ranged from 93% to 100%. All those sponsors that missed a deadline went on to upload the results.
While large pharma was more compliant than biotech, the correlation between compliance and size is not seen among non-industry sponsors. Compliance at Mayo Clinic, the National Cancer Institute (NCI) and the University of California, San Francisco, some of the most active non-industry sponsors, ranged from 16% to 30%.
On average, the delay to the publication of data ran to 424 days.
Widespread non-compliance with the reporting rule could be explained by the fact the requirement is relatively new. Yet, the researchers found no evidence that compliance improved over time. Rather, the compliance rate plateaued at around 40%.
The study authors concluded, “Compliance with the FDAAA 2007 is poor, and not improving…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.”
The researchers said it is “especially concerning” that compliance at NCI, a US government agency, is low. The NCI reported results for 30% of its clinical trials by the deadline.
Included in the study was a link to such an open public audit, which noted that the fines that could have been levied against sponsors currently stands at over $7bn (€6.3bn).
The issue of clinical trial transparency is becoming a focus for both governments and industry, as pressure is applied by organizations, such as AllTrials, for clinical trial results to be made available.
