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    Clinical & TrialsClinical EvidenceMCID

    Minimal Clinically Important Difference

    Smallest change in a measurement that patients perceive as clinically meaningful.

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

    Definition

    MCID anchors interpretation of patient-reported outcomes and many functional endpoints. Pre-specifying MCID is increasingly expected by FDA and HTAs to interpret trial significance.

    What this means in practice

    Especially relevant for orthopedic, neuromodulation, and digital therapeutic trials with PRO-based endpoints.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    FDA·1ICH·1ISO·1
    1. 1
      FDA PRO Guidance
      Bot-blocked
      FDAfda.gov
    2. 2
      ICH Guidelines
      Verified
      ICHich.org
    3. 3
      ISO 14155 Standard Page
      Verified
      ISOiso.org

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