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

https://www.eurekalert.org/pub_releases/2020-01/tl-pss011620.php

News Release 17-Jan-2020
The Lancet

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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Non-reporting of clinical trial results has been well documented since the 1980s, especially those trials finding no evidence of effectiveness for the treatment being tested [4]. However, failing to disclose trial results threatens the integrity of the evidence base of all clinical medicine, breaches participants' trust, and wastes valuable research resources.

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