What Are Clinical Trials?

Cancer specialists regularly conduct studies to test new treatments. These studies are called clinical trials. Clinical trials are available through cancer doctors everywhere not just in major cities or in large hospitals.

Some clinical studies try to determine if a therapeutic approach is safe and potentially effective. Many large clinical trials compare the more commonly used treatment with a treatment that cancer experts think might be better. Patients who participate in clinical trials help doctors and future cancer patients find out whether a promising treatment is safe and effective. All patients who participate in clinical trials are care¬fully monitored to make sure they are getting quality care. It is important to remem¬ber that clinical trials are completely voluntary. Patients can leave a trial at any time.

Clinical trials testing new treatments are carried out in phases.

Phase I- Is the Treatment Safe?

As the first step in testing the research, doctors gather information about the side effects of the treat-ment and decide on the safe dose. Only a few patients in a few places take part in a Phase I trial.

Phase II- Does the Treatment Work?

In this step, doctors test the treatment to see how well it works. Most of the time, fewer than 100 patients are involved in Phase 1 trials.

Phase III - Is the Treatment Better?

Phase III trials compare the new treatment against the current standard therapy and randomly assign patients into one of the two groups. Many people from all over the country take part in these trials.

Phase IV - Are There Better Ways to Use the Treatment?

In this final step, treatments are tested to make sure they are safe and work well over a long period of time. This phase most often occurs once the new treatment has been approved for standard use. Anywhere from several hundred to several thousand people are enrolled in a Phase IV trial.

Only you can make the decision about whether or not to participate in a clinical trial. Before making your decision, it is important to learn as much as possible about your cancer and the clinical trials that may be available to you. Your radiation oncologist can answer many of your questions if you are considering taking part in a trial or contact the National Cancer Institute at 1-800-4-CANCER or www.cancer.gov