What are clinical trials?

How are clinical trials conducted?

Why are clinical trials important?

What is informed consent?

Questions to ask about clinical trials.

What are clinical trials?

Clinical trials are research studies conducted with people. Many trials try to find better ways to prevent or treat diseases, while others test new ways to detect or diagnose a disease. These trials study a new treatment which has been proven to be at least as successful as standard treatment. The goal of the trial is to determine whether the new treatment is superior to the standard treatment for a specific disease. Participants in a clinical trial have, along with their medical doctor, decided that they want to take part in the study and that it is the best treatment choice.

Research protocols for clinical trials have to go through an extensive, independent, peer review process by a separate board of scientists, doctors, nurses, and laypersons not connected with the trial before they are approved. These boards are called "IRBs" (Institutional Review Boards). In addition, these boards review the progress of the trials on a yearly basis. These reviews provide additional assurance to women entering breast cancer research trials that the trials are properly designed and monitored.

Nearly all of the advances in current breast cancer clinical treatment now available to women have come from major randomized clinical trials. These include the use of mammography for screening, the use of adjuvant chemotherapy and hormonal therapy, and the use of lumpectomy and radiation. In addition, these trials provide for long-term follow-up of complications in large numbers of women.

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How are clinical trials conducted?

Medical doctors conducting clinical trials must follow a carefully designed treatment plan called a "protocol." The protocol specifies the doses, frequency and duration of treatment. It also specifies what lab work, scans or other tests are needed, as well as the frequency they are needed.

Studies may have one, two, three, or even four different treatment plans. Participants in studies with more than one treatment plan are randomized (chosen by a flip of a coin) to receive one of the plans. One plan may be the standard treatment, while the other plan(s) may have different therapies, treatment schedules, or higher doses. All participants are monitored closely.

If your treatment does not seem to be helping, the medical doctor can decide to take you off the trial. Also, you can decide to leave the trial at any time. If you leave the trial for any reason, your continued care will not be jeopardized. Many individuals participating in clinical trials can receive their care in the same places where standard cancer treatments are given - cancer centers, hospitals, clinics, and doctors' offices.

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Why are clinical trials important?

Advances in medicine and science are the results of new ideas and approaches developed through research. From clinical trials, researchers learn which approaches are most effective.

Participants take part in clinical trials for many reasons. Usually, they hope for a cure and for a way to contribute to a research effort that may help others. Also, participants in a clinical trial are among the first to receive the new treatments before they are widely available. The care they receive is always the best available.

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What is informed consent?

Informed consent is a key part of a good trial and is required in studies that are federally regulated or funded, as well as those governed by state laws. Informed consent means that as a participant, you are given information that allows you to understand what is involved in the trial, including its potential benefits and risks, so you can then freely decide whether to take part. This consent process is ongoing, and if you enter a trial, you will continue to receive any new information about your treatment that may affect your willingness to stay in the trial. You always have the option to leave the trial at any time.

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Questions to ask about clinical trials:

Before you decide to take part in a clinical trial, you should know as much as possible. Ask your medical doctor for more details on the trial, such as:

• What is the purpose of the study?
• How many people will be included in the trial?
• What does the study involve? What kinds of tests and treatments will I have?
• How are treatments given and what side effects should I expect?
• What are the risks and benefits of each protocol?
• How long will the study last?
• What type of long-term follow-up care is provided?
• Will I have any costs? Will any of the treatments be free? What does my insurance cover? Is financial aid available?

For more information on any of the topics above, please visit www.breastcancerinfo.com.

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