Interactive Graphical Visualization Tool for Safety Data Screening
Ihab G. Girgis, Vivek Viswanathan, Partha Nandy, and Surya Mohanty
Johnson & Johnson Pharmaceutical Research & Development
During the drug development process, extensive patient safety data are collected through clinical trials. Additional safety data are obtained through post-marketing Adverse Event reporting. Exploring and providing pharmacovigilance assessments using such massive data sets is always a challenge. We have developed an interactive graphical visualization tool using S-PLUS to explore safety data (adverse events, vital signs, ECG, liver functions, and different laboratory tests). This tool allows us to link safety data to the population demographics in order to provide a flexible, quick, and effective means to detect and assess any potential safety signals and monitor any drug-related adverse reactions in a sub-population. This new screening capability is developed in-house using S-PLUS Graphlets, and Trellis graphics and provides a powerful web-browsing visualization interface for population and subject-level data screening and evaluation. These tools could easily be enhanced to aid in Exploratory Data Analysis (EDA) prior to model building. Extension of these features to goodness-of-fit plots and other diagnostic graphics generated to evaluate NONMEM models will be highly desirable. The new tool will enable detection of outlier patients and their attributes more readily, thus assisting the modeler in understanding various sources of variability.