This document explains a clinical trial's risks and benefits, what researchers expect of you, and your rights as a patient. Clinical trials may involve risks as well as possible benefits. Whether or not a new treatment will work cannot be known ahead of time. There is always a chance that a new treatment may not work better than a standard treatment, may not work at all, or may be harmful. The treatment you receive may cause side effects that are serious enough to require medical attention.
Clinical trials can raise fears of the unknown.
Understanding the safeguards that protect patients can ease some of these fears. During a clinical trial, doctors will closely watch you to see if the treatment is working and if you are having any side effects. All the results are carefully recorded and reviewed. This group can recommend that a study be stopped at any time. Patients are asked to take part in a clinical trial only if they volunteer and understand the risks and benefits.