Abstract
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.
Highlights
Safety monitoring during clinical trials is an essential component in drug development
As analytical tools became available, comprehensive safety data could be reviewed in using static graphics, usually at certain planned time points
In 2015, the FDA issued draft guidance on safety assessment for investigational new drug (IND) safety reporting which provided advice to sponsors on developing a systematic approach for aggregate safety assessment for human drugs and biological products developed under an IND [6]
Summary
Safety monitoring during clinical trials is an essential component in drug development. A group of clinicians from the Drug Information Association (DIA) were looking for experts who could help them transforming long, tedious data listings into useful information to better address their safety questions These two groups met, realized their common goals, and quickly came up with a solution—a multidisciplinary working group. Collaborations with other world-class groups, such as the Council for International Organizations of Medical Sciences (CIOMS) Drug-Induced Liver Injury (DILI) Working Group, Pharmaceutical Users Software Exchange (PhUSE), and expert hepatologists helped to realize the goal The extent of both internal and external collaborations is a paradigm shift for creating tools to assist in signal detection and safety evaluation in drug development
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