Advanced Visual Analytics for Drug Safety Review


Drug safety data present many challenges with regard to curation, analysis, interpretation, and reporting. Safety endpoints have high variability, are multidimensional, and interrelated which points out to a need to identify novel approaches to explore, analyze, and present these data in some meaningful and insightful way. Visual analytics presents an alternative to the traditional tabular outputs for exploring, assessing, and reporting safety data and present an opportunity to enhance and facilitate evaluation of drug safety and help convey multiple pieces of information concisely and more effectively than tables. Graphical depictions of safety data can play a big role in facilitating communication of safety results with different stakeholders including regulators, investigators, and data monitoring committees. Visual analytics facilitates blending data visualization, statistical, and data mining techniques to create visualization modalities that help users make sense out of safety data with emphasis on how to complement computation and visualization to perform effective and meaningful analyses. Importantly, it is critical to develop readily available tools for stakeholders to use for visual analytics of drug safety data. The tools must take into account considerations revolving around structured assessment driven by safety questions of interest and should consider appropriate user interface parlor. In this discussion, we shall discuss one such tool being developed through a joint collaboration of the ASA, PHUSE, and FDA.

Presented at 2022 Conference