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Final rule clarifies and expands results reporting requirements of the FDA Amendments Act

It is a legal requirement for those responsible for certain applicable clinical trials of FDA-regulated products to register the studies on ClinicalTrials.gov and report results within a defined timeframe, as set out in Title VIII of the FDA Amendments Act (FDAAA). While registration of studies is now common practice, compliance with the requirement to report trial results remains low. This is thought to be due to a lack of understanding of the statutory requirement and who it applies to. The final rule, has now been developed by the Department of Health and Human Services upon consultation with companies, trade associations, academic institutions and the general public, and acts to clarify and expand the requirement for results reporting. The key issues of interest within the final rule were summarised in a special report by Zarin et al., in the New England Journal of Medicine this month.

The authors explain how the final rule clarifies terminology used in the statutory requirements, including the terms “applicable clinical trial” and “controlled” study. In addition, the authors describe the ways in which the rule improves transparency by, for example, expanding the requirements for reporting results of trials for unapproved products, baseline characteristics and adverse event information. Similarly, the rule now defines the level of specification for outcome measures that is required and stipulates that the full up-to-date protocol and statistical analysis plan should be submitted at the time of results reporting. The authors go on to discuss how National Library of Medicine at the National Institutes of Health (NIH) who manage the ClinicalTrials.gov registry will post submitted records within 30 days, highlighting any potential quality control concerns, and will also post registration information for trials of unapproved devices.

By removing ambiguity, the rule, which comes into effect on January 18, 2017, aims to take the decision of posting study results out of the hands of sponsors and others responsible for clinical trials. The authors conclude that as the majority of clinical trials run by US academic medical centres will now fall under the FDAAA, they hope sponsors will take the opportunity to not just meet expectations but go beyond the minimum requirements set out in the act.

ClinicalTrials.gov is offering a series of free live webinars to provide responsible parties with further information about the final rule.

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Summary by Alice Wareham, PhD from Aspire Scientific

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