Visualizing Risks, Benefits, and Uncertainty in Three Dimensions

• Activity Number: 476
• Type: Contributed
• Date/Time: Wednesday, August 4, 2010 : 8:30 AM to 10:20 AM
• Sponsor: Section on Risk Analysis
• Author(s): Richard Forshee*+ and Mark Walderhaug and Arianna Simonetti and Anne Fernando
• Companies: FDA and FDA and FDA and Norfolk State University
• Keywords: benefit:risk analysis ; uncertainty ; biologics ; visualization

Abstract

One of the challenges for Benefit:Risk analysis is to develop tools to help decision-makers analyze the benefits and risks of products while properly characterizing the uncertainty of the estimates of benefits and risks. We have developed a three-dimensional visualization tool where the height of the surface represents the probability that the treatment has a particular risk-benefit coordinate. We provide examples using hypothetical and actual data to map multiple risks and benefits to three-dimensional surfaces based on a user-defined weight matrix to put risks and benefits in a common unit. The visualization tool allows users to compare two therapeutics. The tool shows key properties of distributions that may affect decision-making; integrates data on multiple properties of a medical product; and encourages stakeholders to interact with the visualization to explore what-if scenarios.