It is important to make this decision regarding participating in a clinical trial prior to starting any treatment because you may not qualify for certain clinical trials if you have already received treatment for your cancer. If your doctor does not bring up this subject with you, you may want to ask him or her if participating in a clinical trial is an option for you. If you take part in a clinical trial, you will receive treatment in your doctor's office, a clinic, or a hospital. As part of the study, your health care team will carefully monitor your progress. Some clinical trials may ask you to fill out questionnaires to gather information about the way you feel while you are on treatment. Be sure to fill out these questionnaires if it is requested of you. These questionnaires provide valuable information to cancer researchers about how your cancer treatment is affecting your condition as well as your daily life.

Clinical trials are carried out following a plan of very strict scientific guidelines, called a protocol. The protocol explains everything that will happen in the study. It must be approved by review boards composed of health care professionals and other qualified individuals before the study can enroll patients. Following preclinical or laboratory phases of studies, there are four possible phases of cancer clinical trials in humans, each addressing different questions about the treatment being studied.

Preclinical studies, which are conducted in a laboratory setting, help to assess whether an experimental drug is safe to test in humans. During this stage, the drug usually is studied in animals to answer questions about how a drug works, how it is eliminated, and how the drug might affect pregnancy and offspring.

In phase I clinical trials, doctors study the safety of giving drugs to humans along with looking for the best way to give a medication (e.g., as a pill, an injection, or an infusion). They usually study how the drug is eliminated from the body in humans. In addition, doctors look to determine appropriate doses for further testing. They carefully watch for any side effects. Phase I study drugs are usually given to small groups of humans. During this phase, for drugs used to treat cancer, investigators may be able to identify in which tumors a treatment works best.

In phase II clinical trials, the drug is studied in a larger group. The focus is to study specific cancers to see how well the drug or treatment works. The investigator watches closely for side effects and also watches how the disease responds to the treatment.

In phase III clinical trials, a study drug or treatment generally is compared to a standard existing treatment. Patients usually are randomly assigned to receive either the standard treatment or the new treatment. During the trial, patients are not told which treatment they are receiving but are told what to expect and what to watch for. Also, sometimes the doctor will not be aware of which treatment each patient is receiving. This way, he or she can remain objective about how the disease is responding to the treatment and any side effects that patients may be experiencing.

Phase IV clinical trials study a drug that already has been approved by the Food and Drug Administration (FDA). Pharmaceutical companies often sponsor these trials to study expanded uses of drugs already available.

Before you enter a clinical trial, all of the procedures that are to be done in the trial are explained to you, and then you will be asked to sign an informed consent. By signing the document, you are acknowledging that you understand the potential risks and benefits of the treatment you are to receive or of any tests that may be required. Remember that you can change your mind and withdraw from a clinical trial at any time.

Some patients have said that they chose to not participate in a clinical trial because they thought their health insurance would not cover the cost of this kind of treatment. There are many new laws and programs, which vary from state to state, that may help pay for all or part of the costs of treatment. It is important to have all your questions answered by your insurance representative or health care team.

Additional Information About Clinical Trials can be found:

www.clinicaltrials.gov  - National Institute of Health
www.cancer.gov           - PDQ® Clinical Trials from the National Cancer Institute
www.centerwatch.com - The Information Source for Clinical Trial History