Surrogate outcome measures

A surrogate endpoint is a biomarker intended to substitute for a clinical endpoint that should predict clinical benefit or harm or lack of both (definition by National Institute of Health working group). A valid surrogate measure should aid the diagnosis of the disease, be able to predict the clinical endpoint and be able to monitor the response to the intervention. An ideal surrogate outcome measure should mediate all mechanisms of action to the clinical endpoint. Note Figure 1 of this dataset shows an ideal surrogate outcome measure. Figure 2 shows invalid markers. This dataset is embargoed until 31 July 2025.