MONOCLONAL ANTIBODY CANCER IMAGING AGENT PHASE III STUDIES
This article was originally published in The Gray Sheet
Executive Summary
MONOCLONAL ANTIBODY CANCER IMAGING AGENT PHASE III STUDIES should be designed to demonstrate clinical benefit as well as sensitivity and specificity, FDA says in a draft "Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use." Asserting that clinical benefit should be a "primary efficacy endpoint," the document explains that "sensitivity, specificity, and predictive value are not generally suitable primary endpoints by themselves nor are they satisfactory surrogates for efficacy."