chapter  23
16 Pages

Managing and Monitoring Clinical Trials Andrea Proccacino

OVERVIEW What is a clinical trial? In its purest form, it is an activity designed to test a hypothesis to ultimately reach a conclusion as to whether or not a drug, biologic, medical device, or combination product has any effect on the human body and the disease condition in which it is being tested. The ultimate goal is to demonstrate that the product will improve the subject’s health or quality of life, have an advantage over the current treatment available for that disease or condition, and can be administered safely to the subject.