Clinical Trial Information
What is a clinical trial for patients with cancer?
A clinical trial is medical research in a clinic that tests potential cancer treatments to see if they can help people with cancer. Before a cancer treatment is studied in people, researchers may test their ideas for years in a laboratory. A clinical trial involving people is one of the many steps in a long and careful process. These studies, which include cancer patients, are used to determine whether potential treatments are safe and effective.
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Why are clinical trials important?
Clinical trials are important because they help doctors learn more about cancer and can lead to better treatments and care. Doctors may use the results of clinical trials when they decide on a cancer treatment. If a potential treatment works well in a clinical trial, it may go on to become a FDA approved treatment that may help patients.
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What are the types of clinical trials?
Clinical trials are done in a series of steps, called phases.
Phase I
These are early studies to find out what amount of the potential drug (the dose) can be given safely.
Phase II
A Phase II trial also tests the safety of the potential treatment and tries to find out whether the treatment may be effective. If the treatment is effective, doctors may plan a Phase III study.
Phase III
The goals of Phase III trials are to find out whether the potential treatment is safe and effective compared to a standard of care.
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What is a randomized trial?
A randomized trial is a study in which patients are put into a treatment group by chance. Patients in a randomized trial may or may not receive the potential drug being studied. A randomized trial aims to avoid what is called bias.
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What is a double-blind trial?
In a double-blind trial, neither the patient nor the doctor knows which potential treatment is being given. There is also something called a single-blind trial in which the doctor knows which group the patient is in but the patient doesn't.
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What are eligibility/exclusion criteria?
Every clinical trial has a list of rules that decides who can or cannot participate. These rules, called "eligibility/exclusion criteria," are a list of characteristics a patient must have to join the trial. These may include age, gender (male or female), and type of cancer.
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Should I take part in a clinical trial?
Once you know you have qualified for a trial, only you can decide whether to participate. Before you decide, you should
- Learn as much as possible about your disease.
- Find out what clinical trials are open to you by asking your doctor. You can also visit the website for the National Cancer Institute (NCI), National Institutes of Health (NIH), or American Cancer Society (ACS).
- Discuss your feelings about clinical trials with your doctor and/or nurse, family members, and friends to help you decide what is right for you.
- Learn all about the specific details of the trial you and your doctor may be considering.
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What are the potential benefits and risks of clinical trials?
You may or may not benefit from a clinical trial. Depending on the trial design, you may:
- Receive a potential drug or other treatments that is often not available except in clinical trials because it is not yet FDA approved.
- Get specific medical care from a team that includes doctors and nurses.
- Be carefully watched for any side effects of the potential treatment.
- Be among the first to experience whether the potential treatment being studied is effective.
- Help identify potential treatments that may become FDA approved for cancer patients.
Clinical trials may also have some risks:
- Potential treatments may have side effects that doctors don't yet know about. This is especially true in early phases of clinical trials.
- New treatments may not work at all or as well as currently FDA approved treatments.
- Even if a potential treatment helps others, it may not work for you.
- Those in "randomized trials" will not be able to choose the treatment they get.
- Health insurance may not pay for the study.
- You may have to make more visits to the doctor than you would if you weren't in a clinical trial.
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Where do clinical trials take place?
Clinical trials take place all over the country. If you were in a clinical trial, you might receive the potential drug at a cancer center, a university hospital, a veterans or military hospital, a local medical center, or your physician's office.
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What happens during a trial?
If you decide to be in a clinical trial, you will work with a research team. Team members may include doctors, nurses, social workers, and dieticians. They will provide your care, watch you closely, and give you exact instructions about the study. Being in a clinical trial may mean that you will have more tests and doctor visits than if you weren't in the study. Team members also may continue to stay in touch with you after the trial ends. It is important to follow the research team's instructions.
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Could I be given a placebo?
A placebo, also called a "sugar pill," contains sugar or salt but looks exactly like the drug being used in some studies. Cancer clinical trials rarely use placebos. Most often the potential treatment is compared against current standard medical care for that condition.
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What happens when a clinical trial is over?
After a Phase I or II trial is completed, researchers look carefully at the results and decide whether to move on to the next phase of clinical trial. Or, stop studying the potential treatment because it has not been shown to be safe or effective.
When a Phase III trial ends, researchers look at the results and decide whether or not to apply for FDA approval.
If a potential approach is determined safe and effective by the FDA, the drug may be approved by the FDA and made available for use.
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What are my rights in a clinical trial?
- Before and during a clinical trial, you have a number of rights. Knowing these rights can help you make informed decisions.
- Being in a clinical trial is up to you. Talk with your doctor. Together, you can make the best choice for you.
- If you decide to participate in a clinical trial, doctors and nurses will follow you very carefully to determine how the potential treatment affects you throughout the entire study.
- If you experience a serious side effect, you may be taken off the study.
- You have the right to stop participating in a study at any time.
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What is informed consent?
Informed consent is one of the most important rights someone in a clinical trial has. You must be told all the facts about a study before you decide whether to participate. You will be provided with a written consent form explaining the study that you can take home to read and discuss. The consent form will include information about:
- How the study is designed
- The potential treatments given in the trial
- Possible risks and benefits
- Tests you may be given
You have the right to ask your doctor any questions you might have. People who agree to be in the study are asked to sign the informed consent form.
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Who can answer my questions about clinical trials?
People with cancer and their families have a lot of questions when they are thinking about joining a clinical trial. It is important to discuss all of your questions with your doctor, a cancer specialist (oncologist), and the clinical trial team. Always remember that when it comes to your medical care, no question is silly.
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To find additional clinical trials for Herceptin, please visit www.clinicaltrials.gov.
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