Clinical Trials: Definition

A clinical trial is a study of volunteer patients that answers questions about the most effective ways to treat a condition. Every treatment for breast cancer that is currently available first went through a clinical trial.

Every trial begins with a creative thought for a new way of treating patients. That thought is then developed into a drug, computer model, or other therapy. Once it is fully developed, it must be tested in patients for effectiveness. It must also be compared directly to current therapies to see if it provides any benefit over what is already in use. A clinical trial has an oversight committee, called an institutional review board, or IRB, that is independent from the researchers.

Clinical trials are conducted in hospitals and doctors’ offices. When a new disease therapy is ready to be tested, the disease specialists (doctors and nurses) are given details about the therapy and trial plan. Those specialists then look for patients in their practices who fit the requirements of the trial. Patients receive detailed information about the trial and are then invited to participate. 

When a patient is enrolled in a clinical trial, he or she is watched closely by the trial contact for treatment effects. Close surveillance includes phone calls, physical examinations, blood tests and possible imaging tests. A patient who enrolls in a clinical trial may withdraw from the trial at any time. A patient who decides to stop participating in a trial can resume treatment with standard therapy.

Once a clinical trial is complete, its results are closely evaluated and presented to the medical community. Healthcare providers then use these results to improve treatments for their patients.