Final White Papers produced by the PhUSE Working Groups and Projects
Standard Analyses White Papers
The Analysis and Display White Papers project team has authored multiple White Papers that provide advice on displaying, summarizing, and analyzing various types of data, common across therapeutic areas. The development of standard tables, figures, and listings will lead to improved and harmonized product lifecycle management across therapeutic areas by ensuring that reviewers receive clinically relevant and meaningful analyses of patient safety for benefit-risk assessment. While the White Papers reflect recommendations that would lead to more consistent displays and analyses, the recommendations should not be interpreted as 'required' by any regulatory agency. Another purpose of the White Papers is to improve expertise in safety analytics across the multiple disciplines involved with planning, interpreting, and reporting safety analyses. Educational videos are being created to facilitate the educational goals. Below is a list of final White Papers and additional White Papers and educational videos are in the pipeline.