According to research published in The Lancet on Friday, compliance with US regulations requiring clinical trials to report results within 1 year of completion remains poor, with about one in three trials remaining unreported. The findings also indicate that studies backed by non-industry sponsors such as universities, hospitals and governments are more likely to breach the rules than those sponsored by industry, with US government-backed trials least likely to post results on time at the ClinicalTrials.gov registry.
The rule, which took effect in early 2017, introduced clearer requirements regarding disclosure of trial results, “whether positive or negative,” with non-compliance potentially leading to fines of up to $12,103 per day.
Researchers looking into the extent of compliance under the new regulations examined all 4209 trials registered on ClinicalTrials.gov that were legally required to report results between March 2018 and September 2019. They also evaluated compliance trends, factors associated with compliance, and ranked individual sponsors according to their level of compliance. The authors noted that they only examined the availability of results on ClinicalTrials.gov, and not the quality of the results or their availability elsewhere.
Results showed that non-industry sponsors accounted for 52% of the completed trials, while 71% of the studies involved a drug intervention and 71% were conducted solely in the US. The analysis found that 41% of the completed clinical trials reported results within the one-year deadline, while 36% still had not been reported as of September 16, 2019. The authors also noted that progress has stalled, with the proportion of compliant trials remaining stable since July 2018. In addition, the median delay from completion to submitting results was 424 days, which is 59 days more than the legal reporting requirement of one year.
Meanwhile, industry-sponsored trials were more likely to report results in the required timeframe, than non-industry or US government sponsors, with 50%, 34% and 31% of trials, respectively, being submitted in time. Researchers also found that among sponsors with more experience at conducting large numbers of trials, 66% of studies were submitted in time, compared with 21% for those who have only ever run a very small number of projects. This discrepancy suggests “research experience and robust internal governance processes can contribute to improved performance,” they said.
The authors pointed to lack of enforcement by regulators as the probable reason for the high rates of non-compliance, and urged the FDA to hold trial sponsors to account. “Patients and clinicians cannot make informed choices about which treatments work best when trial results are routinely withheld,” commented Ben Goldacre, who led the research. “Our study has identified over 2400 trials breaching the rules, but to our knowledge the FDA has never levied a single fine or other enforcement action, despite all the levers available to them.” The authors calculated that had the law been strictly enforced, over $4 billion in fines could have been collected up to the end of September 2019.
In an accompanying commentary, Erik von Elm said “any law is only as good as its enforcement,” adding that, “if this rule were to be enforced, academic sponsors would probably make substantial efforts to reduce the number of non- or late-reported trials and to improve data quality.”