Final rule for clinical trial information Reporting in the US
In September 2016, the U.S. Department of Health and Human Services issued a final rule that clarifies how to submit information related to clinical trials on ClinicalTrials.gov, in accordance with FDAAA 801. The final rule specifies which trials must be submitted, when they must be submitted, and whether compliance has been achieved. The definition of an Applicable Clinical Trial is provided, along with the criteria for determining which studies meet such definition. The final rule also expands the FDAAA 801 requirements by requiring the submission of results for trials of unapproved products. The new requirements come into force January 18, 2017 and responsible parties are expected to be in compliance as of April 18, 2017. According to the HHS and the NIH, the scope of the final rule is to provide more information about the scientific results of trials, whether positive or negative, and to help inform healthcare providers and patients regarding medical decisions. The additional information will also help researchers avoid unnecessary duplication of studies, focus on areas in need of study and improve study designs.