3 papers
stat.ME2026
Assessing the Impact of Intercurrent Events on Power and Sample Size for Estimands with Time-to-Event Endpoints
Daniel J Bratton, Fiona Guillard, Sunita Rehal +1
The precise definition of a primary estimand, accounting for intercurrent events (IEs) as per the ICH E9(R1) addendum, is fundamental to the design and interpretation of clinical t…
stat.AP2026
Estimands and the Choice of Non-Inferiority Margin under ICH E9(R1)
Tobias Mütze, Helle Lynggaard, Sunita Rehal +3
Since the release of the ICH E9(R1) addendum on estimands, its application in non-inferiority trials has received far less attention than in superiority settings. A key conclusion…
stat.ME2025
Using off-treatment sequential multiple imputation for binary outcomes to address intercurrent events handled by a treatment policy strategy
Sunita Rehal, Nicky Best, Sarah Watts +1
The estimand framework proposes different strategies to address intercurrent events. The treatment policy strategy seems to be the most favoured as it is closely aligned with the p…