Global Pharmacovigilance and Risk Management Strategies Conference

Safety monitoring and signal detection are essential components in drug development. Thorough reviews of clinical trial safety data at regular intervals are critical to characterize the drug safety profile beginning early and continuing through drug development to protect patient safety and, ultimately, public health. Visualization approaches to evaluate safety data continue to evolve, taking into account how the human brain processes visual information and the advancement of interactive programing tools. The Interactive Safety Graphics (ISG) 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 technical advances. In this session, we will introduce four interactive visualization tools developed by the ISG taskforce: Hepatic Explorer, QT Explorer (cardiac safety, in collaboration with Cardiac Safety Research Consortium, CSRC), Renal Explorer, and AE volcano plot to address common safety topics during drug development. The tools have the capacity to monitor safety data at an aggregated level, as well as to drill down to single patient level. Also, the tools can be applied to facilitate Aggregated Safety Assessment Planning (ASAP) process, in which case grouped terms shall be applied (such as FMQ or SMQ, or company specific grouped terms) to address each safety topics of interest with the corresponding medical concept. Successful user cases will be illustrated. An expert hepatologist and cardiologist will be invited as panelists to discuss the evaluation of hepatic or QTc signals in clinical development programs.