Quantitative Benefit/Risk Assessment: Here and Now
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*Christy Chuang-Stein, Pfizer 


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.