A United States federal judge has ruled that a decision to exempt many clinical trials from a transparency policy is unlawful, and that the results of these studies must now be published.
The ruling is part of a strategic lawsuit brought by the Yale Media Freedom and Information Access and NYU Technology Law & Policy Clinics on behalf of Charles Seife and Dr Peter Lurie, with the support of the Yale Collaboration for Research Integrity and Transparency.
The Food and Drug Administration Amendments Act was enacted by Congress in 2007 to ensure that the results of clinical trials of drugs and medical devices would be publicly available via the ClinicalTrials.gov website.
However, the Food and Drug Administration, National Institutes of Health, and Department of Health and Human Services interpreted the law in a way which meant data from potentially hundreds of trials carried out between 2007 and 2017 were exempt. The ruling clarifies that results from these studies do indeed need to be published.
Cochrane relies on the availability of results from clinical trials to produce high quality and relevant systematic reviews. When trial results – whether positive, negative, or neutral – are not published, it is not possible to make truly evidence-informed decisions about healthcare, and people can be put at risk of harm.