As an active participant in your health care, you will want to take an active role in ensuring you are getting the best possible treatment for lung cancer. One active approach is to research what new drugs and treatment regimens are being tested in clinical trials.

A clinical trial is a research study that evaluates new treatment options. It may also be called a clinical study or research protocol. The purpose of a clinical trial is to determine whether a newer treatment option is safe and effective. It is likely that the current therapy you are receiving for lung cancer was proven effective based on past clinical trials.

During your treatment, the doctor may suggest that you consider being part of a clinical trial. This does not mean that you are being asked to be a "guinea pig" or that there are no other treatment options. A clinical trial is appropriate when there is some reason to believe that the newer treatment being studied may be a good option for some patients.

Clinical trials are carried out in steps called phases. Each phase is designed to answer certain questions. In a phase I study, a new treatment that has been well tested in laboratory and animal studies is given to a small number of patients to determine whether it has anti-cancer activity and can be taken safely by humans. If that treatment is found to be active and safe, a phase II study is done to evaluate the effects of the treatment on various types of cancer. Then, if it is found to be safe and effective, a phase III study is done that compares the new treatment with a standard treatment to see which is more effective. Therefore, when you are in a phase III cancer trial, you will be receiving either a newer treatment or a standard of care, not a placebo such as some people mistakenly think.

Types of Studies in Clinical Trials

Randomized Trial:
A large number of patients with the same disease are assigned to receive either a new treatment or an existing, standard treatment.

Blinded Trial:
Patients are not only randomized, but they are unaware of which treatment they are receiving.

Double-Blinded Trial:
The patient does not know which substance they are receiving and some of the medical staff may not know as well.

Case-Control Study:
Patients are matched on as many characteristics as possible, and then one group is given a particular treatment and the other group is not.

Risks and side effects exist with almost any treatment whether it is a part of a therapy or given in a clinical trial. Many safeguards are in place to make clinical trials as safe as possible and to protect your rights as a patient. Every hospital is required by the US Food and Drug Administration (FDA) to have an Institutional Review Board (IRB) that is made up of doctors from different specialties, nurses, ethicists, administrators, and members of the public who must review and approve any research involving human subjects.

This research is dependent upon patients like you who volunteer to try a new or changed treatment. Patients who enroll in clinical trials are closely monitored. Blood tests, x-rays, and other procedures are performed regularly to monitor all changes in a patient's condition. This provides researchers with data to support making patient care decisions and for documenting research results. An individual has the right to leave a clinical trial at any time.

If you are considering participation in a clinical trial, you will want to discuss it thoroughly with your physician and make certain you understand the informed consent form before you sign it. For thousands of patients, clinical trials provide an opportunity for the best available treatment. Not only do patients frequently express feeling satisfied that they have obtained quality treatment, but they often report feeling a sense of contributing to the greater good for people with cancer in general.