Quantitative Benefit/Risk Assessment: Here and Now
View Presentation *Christy Chuang-Stein, Pfizer Keywords: Pharmaceutical sponsors use a variety of approaches to make internal go/no decisions, including the concept of a clinical utility index to trade off between risk and benefit. Similarly, benefit/risk assessment is important when regulators evaluate a product for marketing approval and payers evaluate it for reimbursement decision. The 4th dimension is to communicate the most pertinent benefit and risk information to patients and healthcare providers. All the above require an agreed-upon framework to facilitate discussion and promote transparency. Our ability to agree on a common framework is an important first step toward common understanding, especially in the public domain. In this talk, we will look at examples of simple frameworks and a more elaborate one proposed recently by a PhRMA (Pharmaceutical Research and Manufacturers of America) working group.
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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