A Standards-Based Tool for Pharmacovigilance

Clinical trial data is insufficient for drug safety purposes since not enough patients are covered. Hence the drug design process can be improved if post-marketed safety data can be used to augment data available from clinical trials. The FDA and WHO are some agencies that make such safety data available for pharmacovigilance purposes. The DOD aims to create a data warehouse that combines such public-domain post-marketed drug/vaccine safety data with pre-marketing clinical trial data. Data mining and other analytical tools will also be needed to discern patterns that can be used to aid drug safety procedures in the drug development process. The proposed work will adopt a standards-based approach to this task. There are a variety of relevant healthcare standards that need to be considered while crafting a solution. Such an approach will ensure that the developed software can interoperate with existing and emerging DOD medical research information systems.