Online Program

Statistical methods for benefit risk assessment

*Bo Yang, Abbvie 
Lanju Zhang, Abbvie 


Risk-benefit analyses are essential for a rational decision in drug development. However, there should be a balance between risk and benefit. How that balance is interpreted differently by different people. Although FDA and EMEA typically require special management for any new drug therapy to assure that the treatment benefits outweigh risks in the clinical setting, i.e., evaluation of the risks and benefits during the new drug-approval process, quantitative risk–benefit assessment is not typically performed. In this talk, we will discuss some of the examples where the risk-benefit analysis is embedded in the randomized and controlled clinical trial setting