Per-Protocol Analysis (PP)

A statistical analysis that includes only those clinical trial participants who completed the study in compliance with the protocol, excluding those with major protocol deviations, poor compliance, or premature discontinuation. Per-protocol analysis estimates the treatment effect under ideal conditions (efficacy) and is the preferred primary analysis for non-inferiority and equivalence trials, where ITT analysis may be anti-conservative.

أمثلة

• Antibiotic non-inferiority trial: PP population excludes patients with wrong pathogen or insufficient drug exposure
• Bioequivalence study: PP excludes subjects with emesis within 4 hours of dosing
• Vaccine efficacy: PP analysis excludes participants who were seropositive at baseline