Data & Quality
Estimand
An estimand is a precise description of the treatment effect a clinical trial aims to estimate, defined by five attributes: treatment, population, variable (endpoint), handling of intercurrent events, and population-level summary.
The estimand framework, formalized in ICH E9(R1) (2019), forces sponsors to specify before unblinding exactly what question their analysis answers. It clarified ambiguities around how to handle treatment discontinuation, switching, rescue medication, and death; intercurrent events that complicate the relationship between assigned treatment and outcome.
Five strategies for handling intercurrent events: treatment policy, hypothetical, composite variable, while on treatment, and principal stratum. Each yields a different estimand and a different statistical analysis.
References
Related terms
Intention-to-Treat (ITT) Analysis
Intention-to-treat (ITT) analysis is a statistical principle requiring that all randomized participants be analyzed in the treatment group to which they were originally assigned, regardless of whether they completed, switched, or never received the assigned treatment.
Statistical Analysis Plan (SAP)
A Statistical Analysis Plan (SAP) is a detailed technical document that specifies, before database lock, every statistical analysis to be performed on a clinical trial's data, including primary and secondary endpoint analyses, handling of missing data, multiplicity adjustments, and sensitivity analyses.
Endpoint (Clinical Trial)
A clinical trial endpoint is a defined, measurable outcome that determines whether the intervention being studied has the intended effect; it is the variable on which the trial's success or failure is statistically evaluated.
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