Despite US Law, Fewer Than Half of US Clinical Trials Report Results by the Required Deadline
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Patients, researchers, pharmaceutical companies, clinicians, amongst others, all rely on the release of clinical trial results. This information is vital to prospective patients looking to make informed decisions about what experimental treatments could prove beneficial. Overall, progress in science and medicine is slowed when researchers fail to provide a report on how a trial was executed, and whether or not a study was successful.
For this reason, in 2007 the FDA Amendment Act required the organization (or individuals) sponsoring US-regulated clinical trials to register and report results on ClinicalTrials.gov within 12 months of primary completion, regardless of whether the results were positive or negative. Subsequently in January of 2017, a ‘Final Rule’ was implemented. This introduced a $10,000 a day fine for non-compliance. The hope was that this fine would ensure timely reporting and reduce the selective publishing of results.
Despite this, The Lancet recently published a report indicating that “trials with non-industry sponsors (such as universities, hospitals, and governments) are far more likely to breach the rules than trials sponsored by industry“. Analyses found that only 41% of completed clinical trials reported results within the deadline, while an additional 36% still hadn’t been reported by September 16, 2019. The lead researcher, Ben Goldacre, mentioned that their study has identified over 2,400 trials breaching the rules, and yet to their knowledge the FDA hasn’t yet taken any action.
Co-author, Nicholas DeVito, had this to say:
“We have established an openly accessible public website at fdaaa.trialstracker.net where fresh data on compliance with FDAAA will be posted every day, identifying each individual overdue trial, and compliance statistics for each individual sponsor. We hope this will help to incentivise sponsors, and provide useful targeted information for all those who aim to comply with the law.”
Holding the FDA and the sponsors of clinical trials responsible is the only way to ensure transparency, fair reporting of trials, and advancement within our field. In the meantime, Dr Goldacre and his team at Oxford are doing their part, using AI and Machine Learning to spot unreported trials, advocating on behalf of all those who could benefit from proper reporting, and encouraging sponsors to report.