Three years ago, the US Food and Drug Administration (FDA) implemented new rules that require clinical trials to report their findings – positive or negative – to a federal database within one year of completing the research. Findings published in The Lancet reveal that one-third of studies remain unreported overall and less than half of clinical trials are reported within the required timeframe. This lag in reporting represents a “substantial threat” for clinical medicine and wastes valuable resources that could be helping to inform the field of medicine.
“Patients and clinicians cannot make informed choices about which treatments work best when trial results are routinely withheld. Clinical trials are not abstract research projects: they are large, expensive, practical evaluations that directly impact patient care by informing treatment guidelines and evidence reviews,” said study author Ben Goldacre of Oxford University in a statement.
“Sponsors are breaching their legal obligations, but also their ethical obligations to the patients who generously participate in clinical trials,” he continued, adding that over 2,400 trials were found to breach the rules, yet to their knowledge, the FDA has not administered a single fine or other enforcement action.
Since the 1980s, federal regulators have known that the results of clinical trials are not fully reported. To combat this, the Final Rule of the FDA Amendment Act required regulated trials to register and report results within 12 months of primary completion, regardless of whether the outcome supported the hypothesis, beginning in January 2018. To assess compliance and quality, researchers examined more than 4,200 trials registered with ClinicalTrials.gov – the world’s largest clinical trial registry – that should have been reported between March 2018 and September 2019.
Overall, compliance is “poor and not improving,” with just 41 percent of completed trial results being reported within the first year and 36 percent of trials not having been reported overall. Trials conducted by non-industry sponsors, like hospitals and universities, were more likely to breach the rules, while the largest offender was the US government despite there being no financial charge to report study findings. The researchers say poor reporting rates are likely due to a lack of enforcement by regulators and that the FDA needs to hold researchers accountable.
“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,” said Dr Erik von Elm of Switzerland’s University of Lausanne, who was not involved in the study.
In January 2017, a secondary rule was implemented to include clearer reporting requirements and added fees of US $10,000 each day that a trial is in non-compliance (now more than $12,000 for adjusted inflation). If the law had been enforced, over $4 billion in fines could have been collected at the end of September 2019.