Communicating Benefit-Risk Analysis Results Using Graphics

• Activity Number: 492
• Type: Topic Contributed
• Date/Time: Wednesday, August 6, 2014 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Richard Forshee*+
• Companies: FDA
• Keywords: Benefit-Risk ; communication ; graphics ; visualization

Abstract

Communicating the results of a benefit-risk analysis is challenging. We must consider multiple risks and benefits, and the risks and benefits are often in different units. Furthermore, the relative importance of each risk and benefit cannot be objectively determined-some value judgments are required. To make things even worse, we usually have some degree of uncertainty about our estimates of the benefits and risks, and the results may be affected by certain modeling assumptions.

Researchers such as Edward Tufte and William Cleveland have argued persuasively that good statistical graphs and other visualization tools can effectively communicate complex information to a wide range of stakeholders. This presentation will explore a range of statistical graphs and other visualizations that may be used to communicate the results of a benefit-risk analysis, including approaches for both quantitative and qualitative analyses.