FDAAA Has Helped With Trial Registration and Results Reporting, Study Finds
The FDA Amendments Act (FDAAA) of 2007 has improved the registration and results reporting for clinical trials supporting US Food and Drug Administration (FDA) approvals, a study on trial reporting for neuropsychiatric indications has found.The study, co-authored by Yale and Harvard medical school researchers, evaluated 142 trials supporting the approval of 37 neuropsychiatric drugs approved by the FDA between 2005 and 2014.
“For clinical trials supporting the FDA approval of new drugs for neuropsychiatric indications, the proportions of trials that were registered and reporting results on ClinicalTrials.gov were significantly higher and publication bias was significantly lower after the passage of the FDAAA in 2007,” the study concluded.
FDAAA mandated that sponsors and investigators register all clinical trials in ClinicalTrials.gov prior to subject enrollment and that results are reported to the website within 30 days after approval of the indication.
The researchers noted that, when compared with pre-FDAAA trials, post-FDAAA trials were “uniformly registered, reported results, published, and published without misleading interpretations … proportions of trials that were registered and reporting results on ClinicalTrials.gov were significantly higher and the degree of publication bias was lower.”
The study says that the results suggest that the FDAAA “likely contributed” to improving the registration, results reporting and publication of clinical trials for drugs used to treat neuropsychiatric indications, although “other factors may also have been in play.”
Earlier studies have demonstrated significant publication bias (ie. positive trials are more likely to be published and published accurately or completely than non-positive trials), but the researchers said that in this study, such publication bias was observed “only among trials that were completed prior to FDAAA enactment, but not afterwards.”
However, the authors of the study cautioned that the study is “cross-sectional and can only establish associations, not causality.”
For more on FDAAA noncompliance, the international initiative AllTrials has launched a new tracking tool to highlight clinical trial sponsors who fail to publish results.
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