A New Paradigm for Safety Data Signal Detection and Evaluation Using Open-Source Software Created by an Interdisciplinary Working Group

Techniques to evaluate large amounts of safety data continue to evolve based on a greater understanding of how the brain processes visual information and the advancement of programing tools. The Interactive Safety Graphics Task Force of the American Statistical Association Biopharmaceutical Safety Working Group has assembled a multidisciplinary team of experts in a variety of domains to develop the next generation of open-source visual analytical tools for safety data based on these advances. The multidisciplinary approach resulted in the rapid development of the first tool, a novel interactive version of the familiar Evaluation of Drug-Induced Serious Hepatotoxicity (eDISH) graphic along with a unique clinical workflow to guide the reviewer through the data analysis. This now serves as the model for the team to expand the open-source platform into a suite of other interactive safety analysis tools.

Automated summary

The American Statistical Association Biopharmaceutical Safety Working Group's Interactive Safety Graphics Task Force has developed the next generation of open-source visual analytical tools for safety data by assembling a multidisciplinary team of experts. Using the familiar eDISH graphic as a foundation, they have created an interactive tool and established a unique clinical workflow to guide data analysis. This approach has served as a model for expanding the open-source platform into a suite of other interactive safety analysis tools.