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Methodological guideline for REA of pharmaceuticals: Surrogate endpoints

Methodological guideline for REA of pharmaceuticals: Surrogate endpoints

This guideline provides a set of recommendations for the selection and assessment of surrogate endpoints when completing a Relative Effectiveness Assessment (REA) of pharmaceuticals.

  • Surrogate endpoints act as substitutes for clinical endpoints and are expected to predict the effect of therapy (benefit and/or harm). An improvement in surrogate endpoint may be or may not be perceived by the patient. In many cases, surrogate endpoints do not themselves directly measure a clinical benefit.
  • A biomarker can be used as a surrogate endpoint if it acts as a substitute for a clinical endpoint that directly measures clinical benefit. When attempting to validate a biomarker as a surrogate endpoint reliably predicting a final clinical endpoint, the evaluation process should consider the following three steps: analytical validation based on extensive documentation, qualification and utilization (IOM 2011).
  • For the purpose of REA, both biomarkers and intermediate endpoints will be considered if used as surrogate endpoints to substitute for a clinical (final) endpoint.
  • Please find the guideline on surrogate endpoints at the bottom of this page.

    Full list of guidelines

    This document is part of the JA1 Final Technical Report as Deliverable “D3-2 WP5_3a3_Surrogate Endpoints”
    NOTE: For the full Technical Report, please follow this link

  • Surrogate Endpoints.pdf

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