A new study has revealed that only 41 percent of US clinical trials reported their findings to the trial registry within the year time limit mandated by the US Food and Drug Administration Amendment Act (FDAAA) 2017 ‘Final Rule’. The researchers highlight that the worst offenders for late- or non-reporting were US government sponsored trials.
The study in The Lancet indicated that trials with non-industry sponsors (eg, universities and governments) were far more likely to be non-compliant than trials sponsored by industry. Among the 4,209 completed clinical trials studied, 31 percent had not published any trial data at all by the end of the study in September 2019 and the median delay in reporting was 424 days.
The researchers in the study claim that high rates of non-compliance are likely to reflect the lack of enforcement by regulators and are calling for trial sponsors to be held to account by the US Food and Drug Administration (FDA).The 2007 FDAAA was designed to prevent clinical trials going unreported and improve public disclosure about results and treatment options. The regulation requires sponsors of most US-regulated clinical trials to register and report results within 12 months of primary completion, irrespective of whether the results are positive or negative. This was then bolstered by the Final Rule in January 2017, which introduced clearer reporting requirements – including fines of up to $10,000 a day for non-compliance.
The research found that 50 percent of trials with an industry sponsor complied with the law, whereas 34 percent of non-industry trials and 31 percent of US Government sponsored studies submitted their findings on time. (50 percent vs 34 percent vs 31 percent of trials submitted on time). Better performance was seen in sponsors with experience running large numbers of trials, as 66 percent submitted on time. However, only 21 percent of sponsors with little experience handed their results over within the year. The study authors indicate this is positive as “research experience and robust internal governance processes can contribute to improved performance.”
Further analyses estimated that, had the law been strictly enforced, over $4 billion in fines could have been collected by the end of September 2019.