Biomarkers and Surrogate End points in Multiple Sclerosis Trials: Regulatory Issues.

Abstract

Evoked potentials have assisted in the diagnosis of multiple sclerosis for years, but the potential to demonstrate pathophysiologic change has prompted a reconsideration of their potential role as outcome measures in clinical trials of multiple sclerosis. The use of any surrogate end point or biomarker in clinical trials requires a thorough understanding of that end point's performance characteristics and utility in a particular setting. This article explores regulatory issues regarding the use of biomarkers and surrogate end points in clinical trials of multiple sclerosis with particular emphasis on challenges faced by evoked potential studies.