Tagged: Surrogate Enpoints

BBCR=Simplifying Clinical Research Interest is increasing rapidly in using surrogate markers as primary measures of the effectiveness of investigational drugs in definitive drug trials. The primary difference between a biomarker and a surrogate marker is that a biomarker is a “candidate” surrogate marker. In contrast, a surrogate marker is a test used and taken to […]

Rare Diseases are conditions that affect less than 200,000 people in the U.S. However, over 7,000 Rare Diseases affect more than 400,000,000 people worldwide, including ~25 million in the U.S. and ~30 million in Europe (1). In recent years, the number of orphan drugs approved has increased significantly. However, developing and marketing orphan drugs remains […]