Visually Displaying Benefit:Risk:Uncertainty in Safety Assessments

• Activity Number: 484
• Type: Invited
• Date/Time: Wednesday, August 3, 2011 : 10:30 AM to 12:20 PM
• Sponsor: Section on Health Policy Statistics
• Author(s): Mark O. Walderhaug*+ and Richard A. Forshee and Arianna Simonetti and Anne Fernando
• Companies: U.S. Food and Drug Administration and U.S. Food and Drug Administration/CBER and U.S. Food and Drug Administration/CBER and Norfolk State University
• Keywords: benefit ; risk ; safety ; efficacy ; visual display ; uncertainty

Abstract

The visual display of safety information is critical to all stakeholders in the process of medical decision-making. While safety information is vital, visualizing benefits and the uncertainty of benefits along with safety information can help keep the decision-making balanced. The visual display of the results of Phase III studies can show a relative equality in the uncertainty of both benefits and risks; however, post-market data streams are asymmetric and can show a more rapid decrease in risk uncertainty because while safety information is reported, post-market efficacy data is generally not reported. As the uncertainty about risk is reduced, the magnitude of risk is likely to increase as low frequency adverse events are reported over time. The ultimate goal of drug/biologic safety decision-making is greater public health, and the visual display of both benefits and risks along with uncertainties helps keep this public health goal in the decision-maker's mind.