The Estimand framework: An introduction
The first presentation is an introduction into the estimand framework. It first discusses why the framework is needed and was developed in an ICH guideline. And then it introduces all the elements of the framework and how they are implemented. The key elements of an estimand - the five attributes - will be discussed in detail. Specific focus will be on intercurrent events and the different strategies how to handle them. An example on the implementation of the framework in primary progressive MS will finally illustrate the framework and its usefulness.
The Estimand framework: Successes, Issues and Examples
The second presentation on the estimand framework will provide first a critical review where the industry and regulatory bodies around the world stand with respect to the implementation of the framework, what has so far worked well and what worked less well. The presentation will then focus on the two challenging areas of the framework and highlight there the issues, the choice of the intercurrent event handling strategy and the subsequent analytical approach. All the issues will then be discussed in three examples. The first one is a discussion of the treatment policy strategy, when it makes sense and when not. The second one deals with the principal stratum strategy in an example in MS. And finally, the third example deals with the implementation of the framework, when a strategy is easy to implement and when it becomes complex. All examples together highlight the challenges but also the usefulness of the estimand framework.
