Surrogate Endpoint Statistical Evaluation for HTA Decision Making

Objective

To provide guidance on emerging good practices for surrogacy evaluation and validation of the relationship between outcomes quantitatively informing HTA. The report will outline different methods to deal with the use of surrogate evidence and how to make appropriate decisions when the relationship between outcomes and their associated treatment effects are used.

Rationale

The task force addresses a gap in guidance in an increasingly important area. This task force will discuss how data can qualitatively and quantitatively be used for HTA purposes to obtain evidence of implicitly or explicitly used relationships, where in some situations sufficient evidence is collected and in other situations only supportive evidence is obtained. Although surrogacy is only one element of multi-dimensional decision-making, creating principles for establishing and understanding surrogacy can help reduce variability in this aspect of decision-making.