US Federal ruling closes loophole on access to clinical trial results

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 theYale Media Freedom and Information Access andNYU Technology Law& Policy Clinics on behalf ofCharles Seife andDr Peter Lurie, with the support of theYale 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.Read more about the case on the Yale Law School websiteRead the case rulingVisit the Cochrane US websiteMonday, March 9, 2020
Source: Cochrane News and Events - Category: Information Technology Authors: Source Type: news