Clinical research is conducted to evaluate the effectiveness and safety of medications medical devices or procedures by studying their effects on human beings. Clinical research trials can be conducted by government agencies such as the National Institutes of Health, researchers affiliated with a hospital or university, independent researchers, or private industry such as pharmaceutical companies. Both the Burke Rehabilitation Hospital and Burke Medical Research Institute conduct clinical trials.
Volunteers, also known as study subject are recruited for clinical trials. Their eligibility to participate in this type of research is based on pre-determined criteria. Subjects are usually divided into two or more groups, including a control group that does not receive the experimental treatment, receives a placebo instead, or receives an already approved treatment for comparison purposes. Government agencies such as the Food and Drug Administration (FDA) either approve or deny approval of new treatments based on the results of clinical trials.