497 – Biopharm Safety Monitoring Working Group: Bayesian and Graphics Approaches Based on Regulatory Guidance
Enhancing Visual Analytics Approaches in Safety Monitoring
Melvin S. Munsaka
Takeda Pharmaceuticals
Kefei Zhou
Theravance
Karolyn K. Kracht
AbbVie
Safety data present many challenges with regard to analysis and interpretation. Safety outcomes have high variability in measurements and are multidimensional and interrelated in nature. The use of tabular outputs for safety data often results in large volumes of output leading to problems in generation, assessment, validation, assembly, comprehension and communication of safety findings. It is well recognized that visual analytics present a useful alternative to tabular outputs for exploring safety data and present a great opportunity to enhance evaluation of drug safety. Graphs can play a big role in facilitating communication of safety results with regulators, investigators, DMC, and other stakeholders and help convey multiple pieces of information concisely and more effectively than tables. In this discussion, we will consider the role of graphical methods in safety monitoring and show to get maximum gain from using visual analytics in SMR, taking into account some considerations that must be borne in mind for effective visualization. We will show via some examples how visual analytics play a critical role in the ongoing evaluation of a drug during study conduct.