What Is a Clinical Study?
A clinical study involves research using human volunteers that is intended to add to medical knowledge.
In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the sponsors. These interventions may be medical products, such as drugs or devices. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or any different than available alternatives. The investigators try to determine the safety and efficacy of the clinical trial. Clinical trials used in drug development are categorized in phases. These phases are defined by the Food and Drug Administration (FDA).