Abstract:
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Defining the scientific questions in a clinical trial is crucial to align its planning, design, conduct, analysis and interpretation. However, practical experience shows that oftentimes specific choices in the statistical analysis blur the scientific question either in part or even completely. The need for more clarity was highlighted by the ICH Steering Committee in 2014, which endorsed a Concept Paper suggested to lead to an addendum to ICH E9. In this talk, we will discuss the need for the estimand framework and share recent experiences highlighting characteristics of estimands that may be of regulatory interest.
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