PP Stats Stories - Estimands

Estimands! What are they?

Estimands have been one of the hot topics in clinical trials in the past few years. Published in 2019, a new addendum to the ICH E9 guideline presented the estimand framework. An estimand is a precise description of the treatment effect reflecting the clinical question posed by a given clinical trial objective. To construct an estimand, you need to define 5 attributes.

1. Population: who are the population of patients being targeted?
2. Treatment: what is the intervention/treatment in the trial?
3. Variable: the endpoint to be obtained for each patient in order to answer the clinical question.
4. Handling of intercurrent events: Examples of intercurrent events affecting measurements could include discontinuation of treatment or use of an additional or follow-up therapy. ICH E9 R1 proposes different strategies for handling these events.
5. Population summary: A population-level summary measure for the variable.

If you are interested in hearing more about estimands or other statistical topics, Plus-Project have a very experienced team of statisticians who can help!