Supporting Medical Decisionmaking Through Dynamic 3D Visualization of Risk, Benefit, and Uncertainty

• Activity Number: 440
• Type: Invited
• Date/Time: Wednesday, August 3, 2011 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Richard A. Forshee*+ and Arianna Simonetti and Mark O. Walderhaug and Anne Fernando
• Companies: U.S. Food and Drug Administration/CBER and U.S. Food and Drug Administration/CBER and U.S. Food and Drug Administration and Norfolk State University
• Keywords: Risk-Benefit assessment ; visualization ; medical decision-making ; biologics ; vaccine

Abstract

One of the challenges for Risk:Benefit analysis is to develop tools to help decision-makers analyze the risks and benefits of products while properly characterizing the uncertainty of the estimates of risks and benefits. 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. The model is applied to historical data from clinical trials and post-market surveillance for a vaccine that was determined to have an elevated risk for an adverse event. The tool shows key properties of distributions that may affect decision-making; integrates data on multiple properties of a medical product; demonstrates the evolution of scientific knowledge, and encourages stakeholders to interact with the visualization to explore what-if scenarios.