What is a surrogate endpoint?
A surrogate endpoint is an outcome that is not itself a direct measure of clinical benefit, such as survival or symptom relief, but is believed to predict it. Examples include blood pressure for cardiovascular risk or tumor size for cancer progression. Surrogates are often used to shorten trial duration or meet regulatory requirements.
Why are surrogate endpoints important in clinical development?
They can accelerate development timelines and regulatory submissions. However, their use requires validation to ensure they reliably predict meaningful outcomes. Payers and HTA bodies may request additional data to confirm long-term value and real-world impact.
