ABSTRACT

What is a clinical trial? In its purest form, it is an activity designed to test a hypothesis and ultimately to reach a conclusion as to whether or not a drug/ biological or medical device product has any effect on the human body and the disease condition in which it is being tested. The 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.