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Estimands: what they are and why we should use them
Brennan C Kahan1, Declan Devane2
1MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.
Journal of Clinical Epidemiology
|November 17, 2025
Summary
Estimands clarify clinical trial results by precisely defining treatment effects and handling postrandomization events. Understanding estimands improves trial design and interpretation for stakeholders.
Area of Science:
- Clinical Trials Methodology
- Biostatistics
Background:
- Postrandomization events in clinical trials, like treatment discontinuation, complicate result interpretation.
- Estimands offer a precise definition of the treatment effect, addressing intercurrent events.
Purpose of the Study:
- To introduce the concept and attributes of estimands.
- To explain strategies for managing intercurrent events in clinical trial analysis.
- To demonstrate the impact of estimand choice on trial design and interpretation.
Main Methods:
- The article outlines five key estimand attributes: population, treatment conditions, endpoint, summary measure, and strategies for intercurrent events.
- It details five main strategies for managing intercurrent events: treatment policy, composite, while on treatment, hypothetical, and principal stratum.
- A practical example of a cognitive behavioral therapy vs. medication trial for mild anxiety illustrates these concepts.
Main Results:
- Different estimand choices lead to varied study designs, analyses, and interpretations.
- Sensitivity analyses can assess the reliability of trial results under different assumptions.
Conclusions:
- Estimands enhance the clarity and relevance of clinical trial results.
- Understanding estimands is crucial for researchers designing trials and stakeholders interpreting outcomes.
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