A clinical study evaluates the effects of medications or surgery on patients. The treatment being studied is called the investigational therapy. To see if the investigational therapy produces the desired results without causing unacceptable side effects, doctors closely follow the medical condition of eligible patients in the study. The FDA reviews the clinical studies of an investigational treatment. If the treatment proves to be beneficial based on the results of these studies, the FDA will approve it for general use.
Researchers conduct clinical studies for the benefit of future patients.
While conducting the study, however, they also must guard the well-being of the enrolled patients. Patients can drop out of a clinical study at any time and for any reason. An IRB is a group of doctors, other health care professionals, and select members of the general public who oversee human clinical studies. The board makes sure that the patients are fully aware of the potential benefits and risks posed by participating in the study. They ensure that patients' safety is closely monitored.