All Times EDT
Keywords: Estimand, intercurrent event, clinical collaboration
The ICH E9(R1) guidance on estimands is becoming a key element of protocol design, for industry and regulatory statisticians alike. The framework has been described as useful for improved study design, intercurrent event handling, data collection and/or analysis for alignment of the data interpretation with the clinical question. Possible topics for discussion: 1. Has this framework factored into your discussions with clinical colleagues to align the study’s clinical question with study design and analysis planning? 2. Do you engage with your clinician about estimands or does your clinician engage you? 3. What factors are considered for choosing the most appropriate strategy for handling an intercurrent event in analysis planning? 4. Participants are encouraged to bring their own questions. The recommended audience for this roundtable is statisticians who are experienced in use of this framework, those who have not yet used it, and those with interest in discussing how to use it effectively.