The IRB considers whether proposed studies are safe and well planned, and whether they will ultimately advance patient care. It also reviews studies to ensure patients are adequately informed about the risks of participating in clinical research. In all studies, the health of each patient is closely monitored during the course of the trial. The rules, known as clinical protocols, vary from study to study. In general, they deal with a study's design, who can participate, and the kind of information people must be given before agreeing to enroll.
Every trial has a principal investigator, usually a physician, who prepares the protocol.
Clinical trials are divided into three distinct stages. Only when the third stage has been successfully completed, and the Food and Drug Administration has given its approval, can a new treatment become part of standard therapy. Phase I trials are designed to determine only the safety of a new therapy. I trials generally enroll only a small number of patients. Phase II trials provide preliminary information about how well a new medication works and generate more information about patient safety.