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    Surrogate Endpoint

    Biomarker or intermediate outcome used as a substitute for a clinical endpoint in regulatory decisions.

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

    Definition

    Surrogate endpoints (e.g., HbA1c for glycemic control, blood pressure for cardiovascular risk) shorten trial duration but require evidence that change in the surrogate predicts clinically meaningful benefit.

    What this means in practice

    Increasingly important for IVD and digital biomarker submissions; FDA maintains a Surrogate Endpoint Table for drug approvals that informs device thinking.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    FDA·2ISO·1
    1. 1
      FDA Surrogate Endpoints
      Bot-blocked
      FDAfda.gov
    2. 2
      ISO 14155 Standard Page
      Verified
      ISOiso.org
    3. 3
      FDA - Clinical Trials and Human Subject Protection
      Verified
      FDAfda.gov

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