What are surrogate endpoints in clinical trials?
In clinical trials, an indicator or sign used in place of another to tell if a treatment works. Surrogate endpoints include a shrinking tumor or lower biomarker levels.
What are examples of surrogate endpoints?
Adult Surrogate Endpoint Table
| Disease or Use | Patient Population | Surrogate Endpoint |
|---|---|---|
| Interoperative hemorrhage | Patients who require reduction of blood pressure to reduce bleeding during surgery | Blood pressure |
| Invasive pneumococcal disease | Patients with invasive pneumococcal disease | Opsonophagocytosis assay titers |
What is a surrogate measure?
In clinical trials, a surrogate endpoint (or surrogate marker) is a measure of effect of a specific treatment that may correlate with a real clinical endpoint but does not necessarily have a guaranteed relationship.
What is a surrogate biomarker?
A surrogate endpoint has been defined as ‘a biomarker intended to substitute for a clinical endpoint’, the latter being ‘a characteristic or variable that reflects how a patient feels, functions, or survives'[4].
What is a surrogate outcome measure?
A surrogate endpoint is a clinical trial endpoint used as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself, but rather is expected to predict that clinical benefit.
Which biomarker is considered as surrogate end points?
Introduction
| End point | Definition* | Example |
|---|---|---|
| Diabetes mellitus | ||
| Surrogate end point | Biomarker or intermediate end point intended to substitute and predict for patient-relevant final end point | HbA1c and glucose control as surrogate for diabetes complications and mortality |