Intention-to-Treat Analysis (ITT)

A statistical analysis strategy in clinical trials that includes all randomized participants in their originally assigned treatment groups, regardless of protocol deviations, non-compliance, or withdrawal. ITT analysis preserves the benefits of randomization, avoids selection bias, and provides a conservative estimate of treatment effect that reflects real-world effectiveness. It is the primary analysis method recommended by regulatory agencies for superiority trials.

例

• Cardiovascular outcome trial: ITT includes patients who discontinued statin but remain in the statin group for analysis
• Antibiotic non-inferiority: ITT may inflate type I error, so per-protocol is co-primary
• Oncology: modified ITT (mITT) includes all randomized patients who received at least one dose