Application of the Estimand Framework to Anesthesia Trials
Anurika P. De Silva,
Kate Leslie,
Sabine Braat
et al.
Abstract:Events occurring after randomization, such as use of rescue medication, treatment discontinuation, or death, are common in randomized trials. These events can change either the existence or interpretation of the outcome of interest. However, appropriate handling of these intercurrent events is often unclear. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E9(R1) addendum introduced the estimand framework, which aligns trial objectives with the desig… Show more
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