Building Open Source Tools for Safety Monitoring: Advancing Research Through Community Collaboration


The Interactive Safety Graphics (ISG) workstream of the ASA-DIA Biopharm Safety Working Group is excited to introduce the safetyGraphics package an interactive framework for evaluating clinical trial safety in R using a flexible data pipeline. Our group seeks to modernize clinical trial safety monitoring by building tools for data exploration and reporting in a highly collaborative open source environment. At present, our team includes clinical and technical representatives from the pharmaceutical industry, academia, and the FDA, and additional contributors are always welcome. The current release of the safetyGraphics R package includes graphics related to drug-induced liver injury. The R package is paired with an in-depth clinical workflow for monitoring liver function created by expert clinicians based on medical literature. safetyGraphics features interactive visualizations built using htmlwidgets, a Shiny application, and the ability to export a fully reproducible instance of the charts with associated source code. To ensure quality and accuracy, the package includes more than 300 unit tests, and it has been vetted through a beta testing process that included feedback from more than 20 clinicians and analysts. The Shiny application can easily be extended to include new charts or applied to other disease areas due to its modular design and generalized charting framework. Several companies have adapted the tool for their own use, leading to interesting discussions and paving the way for enhancements, which demonstrates the power of open source and community collaboration.

Presented at 2019 Conference