Table 1.

Definition of end points

BiomarkerPhysiologic, pathologic, or anatomic measure that is thought to relate to some aspect of normal or pathologic biologic process
Surrogate end pointBiomarker that is a laboratory measurement or physical sign used in therapeutic trials as a substitute for a clinically meaningful end point that is expected to predict the effect of the therapy
Clinical benefit end pointVariable that reflects how a patient feels, functions, or survives
  • Reprinted from reference 20, with permission.