A New York judge has ruled that hundreds of the clinical trials registered on ClinicalTrials.gov are in breach of the law due to unreported results. As noted on the AllTrials website, the case was brought against the US Department of Health and Human Services and concerns trials of unapproved drugs that were registered on ClinicalTrials.gov between 2007 and 2017, which failed to report results. Researchers and institutions have often interpreted the requirement to disclose clinical trial outcomes, as laid down in the 2007 FDA Amendments Act, as only applying to approved drugs.
The ruling establishes that reporting requirements apply regardless of approval status, including for studies registered prior to 2017 when the Amendments Act was clarified and expanded to cover a broader range of studies.
Organisations must now report missing results or risk being in breach of the law.
This may present a particular challenge for academic institutions and researchers, as compliance with reporting requirements by these organisations has been found to be significantly lower compared with industry. A 2019 study reported mean disclosure rates of 74% for trials sponsored by pharmaceutical companies compared with 46% for those with non-industry sponsors.
While the ruling may have clarified that applying reporting requirements to approved drugs only is a misinterpretation of the law, much uncertainty remains. As yet, it is not clear whether the ruling will be appealed and the FDA has not indicated what action it may take. Even prior to the ruling, many organisations were found to be falling short in reporting clinical trial results and the effectiveness and transparency of enforcement has been questioned. What is not in doubt is the time and resources required to report missing data from a decade’s worth of clinical trials. We wait with interest to see just how many of these undisclosed results will be made available and whether this ruling results in fewer future breaches of the law.