Conference Program

RL21: Estimands for Safety Assessments (303576)

*Shanti V Gomatam, FDA 

Keywords: estimand, safety, risk-benefit, analysis population

ICH E9 (R1) discusses estimands in clinical trial setting. In this session the group will discuss estimands in the safety context.

What potential estimands are appropriate and under what contexts? What analysis populations are appropriate? What are the implications for benefit-risk evaluations?