ITT

Also known as: Intention-to-Treat

Analysing every randomised patient in the arm they were assigned, regardless of treatment received.

Definition

Intention-to-Treat (ITT) is the most conservative trial analysis: every patient is analysed in the arm they were randomised to, regardless of crossovers, dropouts, or protocol deviations. ITT preserves randomisation and is generally required as the primary analysis. Per-protocol (PP) analyses exclude deviations and tend to inflate effect sizes.

See also

• Primary endpoint — The pre-specified outcome measure used to determine whether a trial succeeded.

Other clinical terms

• Phase 1 trial
• Phase 2 trial
• Phase 3 trial
• Primary endpoint
• Surrogate endpoint
• CDx