ABSTRACT
A clinical trial, also referred to as clinical study or clinical research, is the overall process of evaluating the safety and efcacy of a medical product or intervention in humans. Importantly, it is investigational and the purpose of a clinical trial is to learn about a product and how it impacts humans. The intention is to treat a select group, not the general population of patients. Successful completion of clinical trials is required for U.S. Food and Drug Administration (FDA) market approval of drugs, biologics and some medical devices and, hence, clinical studies are used in the biotechnology industry to support market approval of biopharmaceuticals. However, the concepts developed for clinical studies incorporate scientic and design elements shared with eld trials of other biotechnology products for which there is no testing in humans, such as eld studies for environmental or agricultural products.
