A Longitudinal Model and Graphic for Beneft-risk Analysis, With Case Study

A novel method for simultaneously visualizing beneft and risk over time is presented. The underlying model represents a subject’s beneft-risk state at a given time as one of fve discrete clinical states, one being premature study withdrawal. The new graphic uses colors to represent each subject’s changing state over the course of the clinical trial. The user can quickly grasp how a treatment affects subjects in aggregate, then further examine how individuals are affected. It is possible to tell whether the benefcial and harmful outcomes are correlated. The method is particularly appropriate for treatments that provide only symptomatic relief. An approved drug for chronic pain is presented as a worked example.