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Short Course requires Pre-Registration and is an additional fee.

The recent release of the ICH E9 addendum on estimands has a profound impact on clinical trial analysis. Health authorities require that methods for analyses and sensitivity analyses target the estimand of interest. This course discusses how to identify and implement analyses approaches as well as sensitivity analyses that are aligned with the estimand. We will illustrate this with case studies on clinical trials with various endpoints (continuous, binary, time-to-event, recurrent events).

Learning objectives

At the conclusion of this short course, participants should be able to:

  • Identify an appropriate primary analysis method that targets the estimand of interest, fully aligned with the ICH E9 addendum
  • Discuss strategies to change assumptions made for the primary analysis in sensitivity analyses
  • Implement appropriate analyses and sensitivity analyses