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?
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC