Original ArticleSeizure Incidence in Psychopharmacological Clinical Trials: An Analysis of Food and Drug Administration (FDA) Summary Basis of Approval Reports
Section snippets
Summary Basis of Approval (SBA) Reports
An SBA report is a review of the pre-clinical and clinical data from the New Drug Application (NDA) for a new drug or new drug indication. The FDA staff includes physicians, pharmacologists, and toxicologists, who prepare reviews of the NDA research data that are then compiled into an SBA report. After the senior FDA staff physician signs off on the completed SBA report, it is made available to the public under the Freedom of Information Act (US Department of Justice 1996), and a subset of the
Results
In Table 1, we rank ordered all of the active compounds based on total seizure incidence unadjusted for PEY for each diagnostic category, and included corresponding PEY and placebo data where it was available.
Discussion
The synthesis and extraction of relevant conclusions from this data set involves recognition of its limitations, evaluation of analyses within indication categories and between active treatment and placebo arms, and interpretation of the results in the context of existing clinical, experimental, and epidemiological evidence.
The clinical trial data reviewed in this study indicated that a relatively high rate of seizures occurred in patients assigned to placebo, which suggests that psychiatric
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