William J. Powers, M.D.-- Departments of
Neurology, Neurosurgery and Radiology
Washington University School of Medicine -- Presented July
11, 2006
Validation of a Biomarker as a
Surrogate Endpoint requires
•
Strong, consistent and
independent demonstration of an
association between the biomarker and the
clinical outcome for
all therapeutic mechanisms/drug classes
•
Evidence that biomarker
accurately predicts both efficacy
and toxicity
• The criterion
for a positive result based on a biomarker must
be of sufficient magnitude to produce a
clinically significant
change
in outcome
