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    Clinical & TrialsClinical EvidenceITT / PP

    Intent-to-Treat vs Per-Protocol

    Two analysis populations: ITT analyzes everyone randomized; PP analyzes only those compliant with protocol.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    ITT preserves randomization and is the primary analysis for superiority trials. Per-Protocol analyses are typically supportive - and primary in non-inferiority trials, where ITT can bias toward 'no difference'.

    What this means in practice

    Non-inferiority device trials require pre-specified analysis populations and consistent ITT/PP results; mismatch is a frequent reason for FDA panel debate.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ICH·2NIH·1
    1. 1
      ICH E9
      Verified
      ICHich.org
    2. 2
      ClinicalTrials.gov
      Verified
      NIHclinicaltrials.gov
    3. 3
      ICH Guidelines
      Verified
      ICHich.org

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