Methodological guideline for REA of pharmaceuticals: Surrogate endpoints
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.