The Promise and Challenge of Benefit: Risk Analysis for Medical Products

• Activity Number: 204
• Type: Roundtables
• Date/Time: Monday, August 2, 2010 : 12:30 PM to 1:50 PM
• Sponsor: Section on Risk Analysis
• Author(s): Richard Forshee*+
• Companies: FDA
• Keywords: Rick Analysis ; benefit:risk analysis ; uncertainty ; biologics ; drugs ; medical devices

Abstract

A growing body of literature is exploring new methods of formal, quantitative analysis of the benefits and risks associated with medical products such as biologics, drugs, and medical devices. Some argue that formal benefit:risk analysis may help regulatory decisions to be more effective, consistent, and transparent, but there are many challenges that must be overcome before quantitative benefit:risk analysis will be widely used. Benefit:risk analysis requires high-quality data on all relevant benefits and risks, including rare but serious risks. Appropriate metrics for comparing different outcomes, for example effective pain relief compared to an increased risk of myocardial infarction, must be developed and accepted by the relevant stakeholders. Finally, methods for properly characterizing both the model and parameter uncertainty of benefit:risk estimates must be improved.