Will Biomarkers Succeed as a Surrogate Endpoint in Heart Failure Trials?
James L. Januzzi Jr.
Information Required to Confidently Use a Biomarker as a Surrogate Endpoint
• A strong correlation between the impact of an intervention on the biomarker and the impact of that intervention on a clinically meaningful endpoint.
• The outcome measure of interest predicted by the biomarker should be remediable through therapeutic intervention.
• Preferably, a biomarker should reflect both benefit as well as risk related to drug exposure.
• Sampling strategies for measurement of the surrogate biomarker, relative to risk for outcome measure must be established, with time course between change in biomarker and substituted outcome well understood.
Reprinted with permission from Ibrahim et al. (5).