Risk Management Working Group: A General Method to Objectively Perform Risk-Benefit Analysis
Topic: A General Method to Objectively Perform Risk-Benefit Analysis
Speaker(s): Richard Matt
Date: Tuesday, 16 January 2024
Time: 2:00 PM - 3:30 PM Eastern Time Zone
Location: Virtual via Zoom
https://incose-org.zoom.us/meeting/register/tZwpcOmrqTgoGND_l4eqrIYqNNJpnFyCdrdm#/registration
Click here to download flyer: Risk Management Working Group: A General Method to Objectively Perform Risk-Benefit Analysis
Meeting Description:
Ever since the phrase “First, do no harm” was coined, the requirement that the benefits of a medical procedure outweigh its risks has been central to medicine. In addition to regulators’ universal requirement that a manufacturer show their product’s benefits exceed its risks before allowing product sales, ‘benefit exceeds risk’ is also central to product availability, documentation compliance, and enforcement decisions. Despite the central importance of benefit-risk analysis, most analyses today present benefits and risks as unrelated facts (even in FDA guidance publications), making comparison difficult and the defense of conclusions as to which is bigger easy to challenge. This presentation shows a novel, systematic approach to benefit-risk analysis. The approach’s cornerstone is to use the same metric to measure both benefit and risk. Measuring both benefit and risk with the same metric makes comparisons of the amount of benefit and risk straightforward and intuitive – leading to conclusions that are significantly more objective and defensible.
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