Surrogate endpoint
A measurable biomarker (e.g. tumour shrinkage, LDL) used as a proxy for a clinical benefit.
Definition
A surrogate endpoint is a biomarker or laboratory measurement intended to substitute for a clinical endpoint. Examples: overall response rate (oncology) as a surrogate for survival, LDL-cholesterol reduction as a surrogate for cardiovascular events. Approval based on a surrogate typically requires confirmatory post-marketing studies.
See also
- Primary endpoint — The pre-specified outcome measure used to determine whether a trial succeeded.
- Accelerated approval — FDA pathway allowing approval based on a surrogate endpoint, requiring confirmatory post-approval trials.