Conference Program

RL41: Sample Size Re-Estimation and Interim Analyses with Different Information Fractions for Time-to-Event Trials (303626)

*Juliana Ianus, Alexion, AstraZeneca Rare Disease 

Keywords: adaptive design, sample size re-estimation, time-to-event data

We consider a time to event confirmatory clinical trial with the primary endpoint tested in a group sequential design with an interim and a final analysis. The uncertainty in the primary estimate may lead to a sample size re-estimation prior to the interim analysis. The main discussion will be on how to adjust the operating characteristics at the interim look when the sample size re-estimation and interim analysis are based on different information fractions.