Tuesday, October 23, 2007

Clinical Trials

Studies of promising new or experimental treatments in patients are known as clinical trials. During a course of treatment for lung cancer, the doctor may suggest that a patient take part in a clinical trial of a new treatment. A clinical trial is only done when there is some reason to believe that the treatment being studied may be of value to the patient. Treatments used in clinical trials are often found to have real benefits.

There are three phases of clinical trials in which a treatment is studied before the treatment is eligible for approval by the FDA (Food and Drug Administration).

The purpose of a Phase I study is to find the best way to give a new treatment and how much of it can be given safely. Physicians watch patients carefully for any harmful side effects. The research treatment has been well tested in laboratory and animal studies, but the side effects in patients are not completely predictable.

Phase II trials determine the effectiveness of a research treatment after safety has been evaluated in a Phase I trial. Patients are closely observed for an anticancer effect by careful measurement of cancer sites present at the beginning of the trial. In addition to monitoring patients for response, any side effects are carefully recorded and assessed.

Phase III trials require entry of large numbers of patients; some trials enroll thousands of patients. One of the groups may receive standard (the most accepted) treatment, so the new treatments can be directly compared. The group that receives the standard treatment is called the "control group. " For example, one group of patients (the control group) may receive the standard chemotherapy for a certain type of cancer, while another patient group may receive another type of chemotherapy that may or may not contain an investigational drug to see if this improves survival. All patients in Phase III trials are monitored closely for side effects, and treatment is discontinued if the side effects are too severe.

Researchers conduct studies of new treatments to answer the following questions:

* Is the treatment likely to be helpful?
* Does this new type of treatment work?
* Does it work better than other treatments already available?
* What side effects does the treatment cause?
* Do the benefits outweigh the risks, including side effects?
* In which patients is the treatment most likely to be helpful?

However, there are some risks. No one involved in the study knows in advance whether the treatment will work or exactly what side effects will occur. That is what the study is designed to discover. While most side effects will disappear in time, some can be permanent or even life-threatening. Keep in mind, though, that even standard treatments have side effects. Depending on many factors, you may decide that a clinical trial may be beneficial in your case.

Enrollment in any clinical trial is completely up to you. Your doctors and nurses will explain the study to you in detail and will give you a form to read and sign indicating your desire to take part. This process is known as giving your informed consent. Even after signing the form and after the clinical trial begins, you are free to leave the study at any time, for any reason. Taking part in the study does not prevent you from getting other medical care you may need.

To find out more about clinical trials, ask your cancer care team. Among the questions you should ask are:

* What is the purpose of the study?
* What kinds of tests and treatments does the study involve?
* What does this treatment do?
* What is likely to happen to me with, or without, this new research treatment?
* What are my other choices and their advantages and disadvantages?
* How could the study affect my daily life?
* What side effects can I expect from the study? Can the side effects be controlled?
* Will I have to be hospitalized? If so, how often and for how long?
* Will the study cost me anything? Will any of the treatment be free?
* If I am harmed as a result of the research, what treatment would I be entitled to?
* What type of long-term follow-up care is part of the study?
* Has the treatment been used to treat other types of cancers?


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