The Lancet: Fewer than half of US clinical trials have complied with the law on reporting results, despite new regulations

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The Lancet: Fewer than half of US clinical trials have complied with the law on reporting results, despite new regulations

Press releases may be edited for formatting or style | January 20, 2020
January 2020 is the third anniversary of the implementation of the new US regulations that require clinical trials to report results within one year of completion (Final Rule of the FDA Amendments Act)--but compliance remains poor, and is not improving, with US Government sponsored trials most likely to breach.

Less than half (41%) of clinical trial results are reported promptly onto the US trial registry, and 1 in 3 trials remain unreported, according to the first comprehensive study of compliance since new US regulations came into effect in January 2017.

The findings, published in The Lancet, indicate 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 [1]--with US Government sponsored trials least likely to post results on time at the world's largest clinical trial registry, ClinicalTrials.gov.

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It has been known for several decades that the results of clinical trials are often not fully reported. To improve public disclosure, and limit selective publishing of results, the US Food and Drug Administration Amendment Act (FDAAA) of 2007 requires sponsors of most US-regulated clinical trials to register and report results on ClinicalTrials.gov within 12 months of primary completion, irrespective of whether the results are positive or negative.

A subsequent 'Final Rule' to the Act took effect in January, 2017. This introduced clearer reporting requirements including fines of up to US$10,000 a day for non-compliance (now US$ 12,103 inflation adjusted). National Institute of Health (NIH) leaders said that the Final Rule would result in "rapid increases" in the percentage of trials registered and shared on the US registry [2].

The authors say that the high rates of non-compliance found in the new study likely reflect the lack of enforcement by regulators, and they call for trial sponsors to be held to account by the FDA.

"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 on patient care by informing treatment guidelines and evidence reviews." says Dr Ben Goldacre from Oxford University, UK, who led the research. [3]

He continues: "Sponsors are breaching their legal obligations, but also their ethical obligations to the patients who generously participate in clinical trials. Our study has identified over 2,400 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. Compliance will only improve when action is taken." [3]

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