Estimands in equivalence trials and non-inferiority trials: a cross-sectional study of EMA scientific advice to drug developers.

ABSTRACT:

Background

The Estimands framework, introduced in the Addendum to ICH E9, provides a structured method to define treatment effects in clinical trials. The main novelty of the framework is the discussion of intercurrent events as part of the treatment effect definition. It is widely believed that the application of the framework to non-inferiority and equivalence trials deserves specific consideration.

Methods

To examine the current practices of using the estimand framework in non-inferiority and equivalence trials, we reviewed the scientific advice provided by the European Medicines Agency to drug developers in 2022. This review aimed to determine how often the estimands framework is used by drug developers and/or recommended by EMA and to describe what intercurrent events a

SUBMITTER: Bergman J 

PROVIDER: S-EPMC12462198 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature