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    Sham Control

    Placebo-equivalent for device trials - a non-therapeutic procedure that mimics the investigational intervention.

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

    Definition

    Sham controls are used when blinding is feasible (e.g., neurostimulator off-state, sham endoscopic procedures) and ethical, providing the strongest control against placebo effects.

    What this means in practice

    Sham-controlled device trials raise ethics, IRB, and patient acceptance challenges; FDA has issued specific guidance on appropriate use.

    Primary references

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

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