Data & Quality
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.
ITT preserves the balance of prognostic factors created by randomization and provides an unbiased estimate of treatment effect under realistic conditions of imperfect adherence. It is the primary analysis required by ICH E9 for confirmatory trials.
Complementary analyses include modified ITT (excludes patients who never received treatment), per-protocol (only protocol-compliant patients), and as-treated (analyzes by treatment actually received). Each addresses a different scientific question and is reported alongside ITT for sensitivity.
Related terms
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.
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.
Randomization
Randomization is the process of assigning clinical trial participants to treatment groups by chance, eliminating selection bias and producing comparable groups for unbiased estimation of treatment effects.
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