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Clinical Trials

Clinical trials are also called research studies or protocols. There trials test new treatments in people with cancer. A clinical trial is one of the final stages of a long and careful cancer research process. Studies are done with cancer patients to find out whether promising approaches to cancer treatment are safe and effective

Before a new treatment to become part of standard treatment, it must first go through 3 or 4 clinical trial phases. The early phases make sure the treatment is safe. Later phases show if it works better than the standard treatment. Most trials conducted at Medical Center Clinic are phase II or phase III.

You may be eligible to participate in a clinical trial if you have breast cancer, prostate cancer, lung cancer, or colorectal cancer. Your doctor will let you know if you may be eligible.

Purpose	Number of people who take part
Phase I
To find a safe dose To decide how the new treatment should be given To see how the new treatment affects the human body	15-30 people
Phase II
To determine if the new treatment has an effect on a certain cancer To see how the new treatment affects the human body	Less than 100 people
Phase III
To compare the new treatment (or new use of a treatment) with the current standard treatment	From 100 to thousands of people
Phase IV
To further assess the long-term safety and effectiveness of a new treatment	Several hundred to several thousand people

Before agreeing to take part in a trial, you have the right to:

Learn about all your treatment options
Learn all that is involved in the trial - including all details about treatment, tests, and possible risks and benefits
Discuss the trial with your doctor and your family

After discussing aspects of the study with you, the doctor or nurse will give you an informed consent form to read. The form includes written details about the information that was discussed and also describes the privacy of your records. If you agree to take part in the study, you sign the form. But even after you sign the consent form, you can change your mind at any time.

Possible benefits of participating in a clinical trial include:

Clinical trials offer high-quality cancer care. If you are in a randomized study and do not receive the new treatment being tested, you will receive the best known standard treatment. This may be as good as, or better than, the new approach.
If a new treatment is proven to work and you are taking it, you may be among the first to benefit.
By looking at the pros and cons of clinical trials and your other treatment choices, you are taking an active role in a decision that affects your life.
You have the chance to help others and improve cancer treatment.

Whenever you need treatment for your cancer, clinical trials may be an option for you. Choosing to join a clinical trial is something only you, those close to you, and your doctors and nurses can decide together.