07 CVARS Package for Interactive Visuals on Safety data and FDA Medical Queries (FMQs)

Oregon Convention Center 

Drug safety data present many challenges regarding data curation, analysis, interpretation, and reporting. Visual analytics presents an alternative to the traditional tabular outputs for exploring, assessing, and reporting safety data and presents an opportunity to enhance and facilitate the evaluation of drug safety. Graphical depictions of safety data can help facilitate better communication of drug safety findings by blending data visualization, statistical, and data mining techniques to create visualization modalities that help users make sense of safety data with. Developing readily available tools for visual analytics of drug safety data that take into account considerations revolving around structured assessment driven by safety questions of interest is desirable along with considerations for user interface parlor. This poster will highlight an R package CVARS for generating interactive forest and volcano plots for adverse events and FDA Medical Queries (FMQs) analysis outputs for inclusion in submissions to the FDA. This work is based on the ongoing collaboration among the ASA, PHUSE and the FDA.