TL11: Statistical methods in benefit-risk assessment
*Yueqin Zhao, FDA 

Keywords: MCDA, visualization

Although regulatory agents evaluate the risks and benefits of any new drug during the new drug-approval process, no consensus on quantitative assessment of benefit risk has been reached. Various structured benefit risk models and methods have been proposed, such as Multi-criteria decision analysis (MCDA), Quality-adjusted time without symptoms and toxicity (Q-TWiST), number needed to treat (NNT) and number needed to harm (NNH), Benefit-less-risk analysis(BLRA), Risk-benefit Contour (RBC), and so on. In this roundtable, we will address the following questions: 1. What are the commonly used models and statistical methods in benefit-risk assessment, in both the industry and regulatory agency? What are the advantages and disadvantages? 2. What are the commonly used visualization methods in benefit-risk evaluations? 3. How can the benefit-risk assessment be bridged between pre-approval clinical trials with the post-approval surveillance?