Wiki Resources for Answering Common Clinical Safety Questions with Graphs
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*Susan Duke, GlaxoSmithKline 

Keywords: safety, graphics, communications

The volume and complexity of safety information in clinical trials can make it challenging for the sponsor and regulatory reviewer alike, and may cause important relationships to be missed over the life-cycle of the product. The appropriate use of graphics can more effectively and efficiently communicate critical safety information to a variety of stakeholders. Especially for common safety questions, encouragement of best practice and standard graphical presentation of clinical safety information is needed. To that end, a team of statisticians (20 from FDA, 14 from industry and 2 from academia) undertook to create a Safety Graphics Wiki. The goal was to develop a palette of graphics for visualizations of clinical trial safety data. This presentation will describe the standard graphs available in the wiki to answer common questions about adverse events, ECGs, and lab/liver parameters. We anticipate that having standard graphical representations for elucidating answers to commonly asked questions will improve the abilities of sponsors and regulators alike in understanding the safety profiles of new medicines, which ultimately benefits patients and their doctors in making well-informed choices.