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28 April 2022

Khadija Rantell, Alex Ocampo, Samvel Gasparyan, Oliver Keene, Inês Antunes dos Reis 

When an intercurrent event in itself is considered to be informative about the treatments' effect on patients' outcomes, the intercurrent event is often incorporated into the definition of the variable. The ICH E9 (R1) addendum refers to this as the composite strategy. In this event, speakers will present different composite estimand strategies for clinical trials, the analyses that target these estimands (e.g., trimmed means, rank-based approaches), and regulatory considerations for clinical trials with composite estimands and endpoints. A discussant will reflect on the presentations.

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