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The ICH E9(R1) Addendum has provided a framework for discussing interesting estimands that may be of relevance in RCTs affected by the intercurrent events of various types. The Addendum is of fundamental importance because it provides principles regarding the analysis of RCTs and observational studies with intercurrent events. One of the strategy that is proposed is the Principal Stratum strategy.
Here, we will discuss issues regarding the application of such strategy, offering guidelines regarding which data should be collected at baseline and post-treatment to support assumptions and analysis. Various approaches to Principal Stratification analysis will be reviewed with associated carefully planned sensitivity analysis to assess robustness of conclusions to deviations from such assumptions, as well as to choice of an analytic approach more broadly (e.g., parametric vs semiparametric or non parametric). Examples will be used to illustrate concepts.
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