TL38: Decision analysis in the development of medical products
*Bruce Binkowitz, Merck, Sharpe, and Dohme 

Keywords: decision analysis, benefit-risk

Decision analysis (DA) has been used more and more in the development of drugs and medical devices, either in making the decision of go or no-go for medical products in the course of clinical trials or in making the decision of approval or no-approval in assessing the benefit-risk profile. In this roundtable topic, we will discuss the use of DA with cases studies, new ideas and methods, existing problems, etc.

1. In a medical products development process, does your team use a formal DA process to move to the next step? 2. How do you feel about quantitative DA being used in making approval/not decisions of products (e.g. diagnostic devices, drugs, biologics) in the FDA? 3. Safety & effectiveness may be determined by balancing the benefits & risks of true & false positives against true & false negatives, even when they have differing consequences. How do you weigh these risks?