Disease: Breast Cancer: Choosing a Breast Cancer Clinical Trial

    What Is a Clinical Trial?

    A clinical trial is a research program conducted with patients to evaluate a new medical treatment, drug or device. The purpose of a breast cancer clinical trial is to find new and improved methods of treating the disease. Clinical trials make it possible to apply the latest scientific and technological advances to patient care.

    During a breast cancer clinical trial, researchers, usually physicians, use the best available treatment as a standard to evaluate new treatments. These treatments may be a new drug, surgery or an alternative medicine.

    First, researchers study new treatment options in the laboratory in test tubes and animals. If those results are promising, new treatments are further evaluated in a small group of people, and, finally, in a larger clinical trial.

    When a new medical treatment is studied for the first time in humans, no one knows exactly how it will work. With any new treatment, there are possible risks as well as benefits. Clinical trials help physicians discover the answers to these questions:

    • Is the treatment safe and effective?
    • Is the treatment potentially better than the treatments currently available?
    • What are the side effects of the treatment?
    • Does the treatment have any possible risks?
    • How well does the treatment work?

    What Are the Different Types of Breast Cancer Clinical Trials?

    All clinical trials are conducted in phases, each designed to find out specific information. Each new phase of a clinical trial builds on information from previous stages.

    Participants may be eligible for clinical trials in different phases, depending on their health. Most clinical trial participants take part in Phases III and IV.

    Phase I clinical trials study the safety of the new treatment.

    Phase II clinical trials occur if the treatment is found to be safe in the phase 1 trial. Phase II studies look at whether the treatment is effective.

    Phase III clinical trials compare the new treatment with the standard treatment to determine if it's any better.

    If a treatment does well in phase II studies, it is often approved for use by the U.S. Food and Drug Administration (FDA).

    Phase IV clinical trials occur after the drug is approved FDA. These studies look at ways to use the new treatment more effectively. For example, in phase IV trials researchers may test a drug in combination with other drugs. Or they may study a new dose. Or they may study the drug's effectiveness to treat a particular disease or a select group of patients.

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    What Are the Advantages of Participating in a Breast Cancer Clinical Trial?

    • You may receive a new treatment before it is widely available to the public.
    • You can provide researchers with the information they need to continue developing new procedures and introducing new treatment methods.
    • Your treatment costs may be decreased, since many of the tests and physician visits that are directly related to the clinical trial are paid for by the company or agency sponsoring the study. Be sure to discuss your treatment costs with the physicians and nurses conducting the clinical trial.

    What Are the Disadvantages of Participating in a Breast Cancer Clinical Trial?

    • All of the risks and side effects of the new treatment usually are not known at the beginning of the clinical trial. There may be unknown side effects, as well as hoped-for benefits. It's important to note that most treatments have potential side effects. Patients are informed of any known possible side effects before they join a clinical trial. They're also informed of any "new" side effects that become known while they are participating in the trial.
    • If you participate in a randomized clinical trial, you may not receive the new treatment being studied. Many breast cancer clinical trials compare a new treatment along with current therapy versus the current therapy alone. Participants are randomly assigned to one or the other group. This will be explained to you before you decide to take part.
    • As with other forms of therapy, the new treatment may not work for you, even if it helps others.
    • Insurers do not always cover all of the costs associated with taking part in a clinical trial. Be sure to talk to your insurance provider before you decide to participate.
    • There may be inconveniences, such as more frequent testing, more time at the doctor's office, and travel commitments.

    © 2005-2015 WebMD, LLC. All rights reserved.
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    Who Looks Out For Me if I Decide to Enroll in Breast Cancer Clinical Trial?

    Clinical trial participants are willing volunteers. Even though patients may be asked by their physicians to take part in a clinical trial, it is up to you to make the final decision. However, there are many safeguards in place to look out for the welfare of volunteers. These safeguards can't guarantee that you won't have complications, but they try to reduce risk as much as possible.

    What Happens if I Join a Breast Cancer Clinical Trial?

    Before you take part in any research study, you will be asked to give informed consent to participate. Informed consent means that as a patient, you are given all available information so you can understand what is involved in a specific clinical trial. The physicians and nurses conducting the study will explain the treatment to you, including its possible benefits and risks.

    You will be given an informed consent form to read and consider carefully. Before signing, be sure you find out as much as possible about the clinical trial, including what risks you may face. Ask the physician or nurse to explain parts of the form or the trial that are not clear. (See the section, "Important Questions to Ask".)

    You are free to decide whether or not you want to take part in the trial. If you decide to participate, you will sign the consent form. If you do not want to participate in the trial, you may refuse. If you choose not to participate in the trial, your care will not be affected in any way.

    Your signature on the informed consent form does not bind you to the study. Even if you sign the form, you are free to leave the trial at any time to receive other available treatments.

    The informed consent process is ongoing. After you agree to participate in a breast cancer clinical trial, you will continue to receive any new information about your treatment that may affect your willingness to stay in the trial.

    © 2005-2015 WebMD, LLC. All rights reserved.
    Source article on WebMD

    What Are the Advantages of Participating in a Breast Cancer Clinical Trial?

    • You may receive a new treatment before it is widely available to the public.
    • You can provide researchers with the information they need to continue developing new procedures and introducing new treatment methods.
    • Your treatment costs may be decreased, since many of the tests and physician visits that are directly related to the clinical trial are paid for by the company or agency sponsoring the study. Be sure to discuss your treatment costs with the physicians and nurses conducting the clinical trial.

    What Are the Disadvantages of Participating in a Breast Cancer Clinical Trial?

    • All of the risks and side effects of the new treatment usually are not known at the beginning of the clinical trial. There may be unknown side effects, as well as hoped-for benefits. It's important to note that most treatments have potential side effects. Patients are informed of any known possible side effects before they join a clinical trial. They're also informed of any "new" side effects that become known while they are participating in the trial.
    • If you participate in a randomized clinical trial, you may not receive the new treatment being studied. Many breast cancer clinical trials compare a new treatment along with current therapy versus the current therapy alone. Participants are randomly assigned to one or the other group. This will be explained to you before you decide to take part.
    • As with other forms of therapy, the new treatment may not work for you, even if it helps others.
    • Insurers do not always cover all of the costs associated with taking part in a clinical trial. Be sure to talk to your insurance provider before you decide to participate.
    • There may be inconveniences, such as more frequent testing, more time at the doctor's office, and travel commitments.

    © 2005-2015 WebMD, LLC. All rights reserved.
    Source article on WebMD

    Who Looks Out For Me if I Decide to Enroll in Breast Cancer Clinical Trial?

    Clinical trial participants are willing volunteers. Even though patients may be asked by their physicians to take part in a clinical trial, it is up to you to make the final decision. However, there are many safeguards in place to look out for the welfare of volunteers. These safeguards can't guarantee that you won't have complications, but they try to reduce risk as much as possible.

    What Happens if I Join a Breast Cancer Clinical Trial?

    Before you take part in any research study, you will be asked to give informed consent to participate. Informed consent means that as a patient, you are given all available information so you can understand what is involved in a specific clinical trial. The physicians and nurses conducting the study will explain the treatment to you, including its possible benefits and risks.

    You will be given an informed consent form to read and consider carefully. Before signing, be sure you find out as much as possible about the clinical trial, including what risks you may face. Ask the physician or nurse to explain parts of the form or the trial that are not clear. (See the section, "Important Questions to Ask".)

    You are free to decide whether or not you want to take part in the trial. If you decide to participate, you will sign the consent form. If you do not want to participate in the trial, you may refuse. If you choose not to participate in the trial, your care will not be affected in any way.

    Your signature on the informed consent form does not bind you to the study. Even if you sign the form, you are free to leave the trial at any time to receive other available treatments.

    The informed consent process is ongoing. After you agree to participate in a breast cancer clinical trial, you will continue to receive any new information about your treatment that may affect your willingness to stay in the trial.

    © 2005-2015 WebMD, LLC. All rights reserved.
    Source article on WebMD

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