Keywords: safety analysis plans, crowd sourcing, integrated summaries, clinical trial reporting, data standards
The Analysis and Display White Papers Project is an ongoing initiative in the industry-wide “Standard Analyses and Code Sharing” PhUSE Computational Science Working Group. It delivers recommendations on the analysis and reporting of data that are common across therapeutic areas, including demographics, subject disposition, safety assessments, pharmacokinetics and special topics like hepatotoxicity and thorough QT analyses. Ten white papers are at various stages of development, including six that have been finalized. The latest white paper to be finalized covers analyses and displays for adverse events. This project provides an organized platform for shared learning of improved methodologies (including visual analytics) that can lead to earlier safety signal detection, better characterization of the safety profile of molecules, and improved efficiency. I will present the overall goals and timeline, provide an update on white papers completed to date, and share examples of recommended data displays.