Flexible Pharmacovigilance System for Data Visualization and Signal Detection

The objective of this Phase I proposal is to lay the groundwork for the integration of specific novel drug-safety concepts into a tool for data analysis and visualization at DOD. The novel concepts include: 1) A flexible, probability-based model which assesses the signal strength of both rare and common adverse events without complex "shrinkage" algorithms; 2) A "pharmacovigilance map", which allows visual assessment of drug safety profiles; 3) A lattice-based visualization technique particularly suited to drug interactions (drug-drug, drug-vaccine, drug-demographic, drug-disease) which can help distinguish true drug interactions from "innocent bystander" effects; 4) An underlying data model for all three of the concepts above, which can accommodate drug safety data from clinical trials, spontaneous reporting systems, and patient-oriented databases such as electronic medical record systems.