Intent-to-Treat (ITT) is a statistical analysis principle in which participants are analyzed according to the treatment group they were originally assigned, regardless of adherence or protocol deviations.
This approach preserves the benefits of randomization and helps reduce bias related to dropouts, treatment switching, or missing data. ITT is commonly the primary analysis population for efficacy in randomized controlled trials. Regulators often expect ITT analyses because they reflect real-world use patterns and provide conservative, credible estimates of treatment effect. Clear ITT definitions in the statistical analysis plan support transparency and interpretability of trial outcomes.