Per-Protocol Analysis (PP)
PPA 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.
उदाहरण
- 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
क्या आप जानते हैं?
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. …