PS01: From Estimands to Estimation: Are We Aligned?

The focus of this session will be on estimation approaches that are aligned with estimands and the clinical question of interest. Addressing missing data and terminal events in clinical trials is a complex challenge. To tackle this, various strategies and imputation methods are available, each bringing different assumptions and impacts on estimation bias, variability, sample size, and power for a clinical trial. It's crucial that the assumptions for these analysis approaches are firmly anchored to the defined clinical question of interest. Additionally, they depend on multiple factors, including the reasons for missing data and the drug's mechanism of action (MoA). We have an engaging lineup of three talks for this session, featuring two industry speakers and a regulatory speaker. This session will wrap-up with a Q&A.