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Visual Analytic Approaches for the Analysis of Spontaneously Reported Adverse Events...

 Visual Analytic Approaches for the Analysis of Spontaneously Reported Adverse Events in Post-Market Surveillance


Richard C. Zink, PhD, Principal Research Statistician Developer, JMP

While randomized clinical trials are the gold standard for evaluating the efficacy of a new intervention, the available sample size is often insufficient to fully understand its safety profile. The risk a new therapy may pose may not be well-understood until it has been on the market for many years, taken by individuals who differ from those studied under the inclusion criteria of the clinical development program. Spontaneously reported adverse events (SRAEs) are collected by regulatory agencies, pharmaceutical companies and device manufacturers to monitor the safety of a product once it reaches the market. These data are generally obtained from physicians, patients or the medical literature. SRAEs present a unique challenge in that there is no convenient measure for the total number of individuals using an intervention. In other words, there is no clear denominator to define an adverse event incidence for a particular drug. In order to identify potential safety signals, we employ disproportionality analysis methods to compare the rate at which a particular event of interest co-occurs with a given drug with the rate this event occurs without the drug in the event database. We describe how dynamically interactive graphical displays of disproportionality can streamline analyses of SRAEs in post-market surveillance.

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