Surrogate Endpoint
A biomarker or intermediate outcome used as a substitute for a clinically meaningful endpoint (such as survival or symptom improvement) in a clinical trial, intended to predict clinical benefit. Validated surrogate endpoints enable shorter and smaller trials, facilitating faster regulatory approval. However, surrogates that do not reliably predict clinical outcomes can lead to approval of ineffective or harmful drugs.
示例
- HbA1c reduction as surrogate for diabetes complications (well-validated by UKPDS)
- Tumor shrinkage (objective response rate) as surrogate for overall survival in oncology (variably validated)
- LDL-C reduction as surrogate for cardiovascular events (validated for statins, questioned for other mechanisms)
您知道吗？
A biomarker or intermediate outcome used as a substitute for a clinically meaningful endpoint (such as survival or symptom improvement) in a clinical trial, intended to predict clinical benefit. Validated …