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PSI One Day Meeting: New Emerging Topics Around Estimands and ICH Addendum, Jan 2019: Non-Inferiority Trials and the ICH E9 Estimands Framework

29 January 2019

The talk will discuss the application of different strategies for intercurrent events in the non-inferiority setting and what additional comparisons of intercurrent events will be helpful.

The estimand framework described in the draft addendum to the ICH E9 regulatory guideline has led to a reappraisal of non-inferiority trials. Currently, these trials often make use of a Per Protocol Population where subjects who violate the protocol are excluded. In the estimands framework, protocol violations after randomisation can be seen as intercurrent events and subjects who do not fulfil inclusion/exclusion criteria can potentially be excluded based on the population of interest. Therefore, the role of a Per Protocol Population is substantially diminished or eliminated entirely.
The strategy to be employed for intercurrent events such as discontinuation of randomised treatment in the non-inferiority setting has not been established yet.  For example, some statisticians favour use of a hypothetical strategy for key intercurrent events, while others believe a treatment policy strategy provides more robust estimation. This talk will use a case study of a trial in COPD to illustrate how to implement the estimands framework to a non-inferiority trial.  

The talk will discuss the application of different strategies for intercurrent events in the non-inferiority setting and what additional comparisons of intercurrent events will be helpful.  

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