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

  • Jonathan D. NortonEmail author
Statistics

Abstract

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.

Keywords

Beneft-risk Graphics Longitudinal Safety Missing data 

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Copyright information

© Drug Information Association, Inc 2011

Authors and Affiliations

  1. 1.Division of Biometrics II, Office of Biostatistics, Center for Drug Evaluation and ResearchFood and Drug AdministrationSilver SpringUSA

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