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What is a Clinical Trial

Cancer treatment clinical trials are research studies to find better ways to treat cancer. It is important that men and women of all ages and backgrounds take part in these studies so that what is learned will help cancer patients now and in the future.

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Clinical trials often compare the most accepted cancer treatment (standard treatment) with a new treatment doctors hope will be better.

Each study has rules about who can and cannot participate—such as age, sex, or type of cancer. Think about asking your doctor if you can take part in a study. Your doctor will explain the clinical trial to you. Clinical trials include only people who choose to take part. Please take your time to make your decision about taking part. You may discuss your decision with your friends and family. You also discuss it with your health care team. If you have any questions, you can ask your doctor for more explanation about the clinical trial or research study.

Each study’s protocol describes the characteristics that all patients in the study must have. Called eligibility criteria, these guidelines differ from study to study, depending on the research purpose. They may include age, gender, the type and stage of cancer, and whether cancer patients who have prior cancer treatment or who have other health problems can take part.

Using eligibility criteria is an important principle of medical research that helps produce reliable results. During a study, they help protect patient safety, so that people who are likely to be harmed by study drugs or other treatments are not exposed to the risk. After results are in, they also help doctors know which patient groups will benefit if the new treatment being studied is proven to work. For instance, a new treatment may work for one type of cancer but not for another, or it may be more effective for men than women.

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Why participate in a clinical trial?

Before you join a study, a doctor, nurse, or another person on the research team will explain why the study is being done, and what will happen during they study. You can ask any questions you have about the study.

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You will also be given a consent form to read. The consent form will explain:

  • The exact plan for each step in the study
  • What side effects you may have
  • How the study may affect your daily life

You should ask questions about any part of the consent form you do not understand. If you decide to take part in the study, you will be asked to sign the consent form. Even if you sign the consent form, you can still change your mind and stop at any time.

If you join a study that compares treatments, you will get either:

  • The best accepted treatment for the kind of cancer you have (called standard treatment)
  • A new treatment doctors hope will be better than the standard treatment
  • What doctors learn in studies also helps people who may get cancer in the future.

It is not known for sure if the new treatment in the study will help you more than the standard treatment for your cancer. Treatments in studies have side effects. Research studies have costs, and health insurance does not always pay for all your costs in a study. It’s important to talk about these costs with a doctor, nurse, or social worker.

Here are some questions to ask before you agree to take part in a clinical trial:

  • Why is the study being done?
  • How will it help me?
  • What kinds of tests and treatments are part of the study?
  • How am I protected?
  • How could the study change what I do every day?
  • What will happen to my cancer with or with this treatment?
  • What other treatments could I get if I don’t take part in the trial?
  • What are possible short-and long-term side effects for me and my family to think about?
  • How do the risks and side effects of the standard treatment compare with the treatment being studied?
  • How long will the study last?
  • Will my insurance cover my being in this study?
  • Will I have to stay in the hospital during the study? If so, how often and for how long?
  • Will I have extra costs because of the study?
  • How will I be checked after the study?
  • How long do I have to make up my mind about joining this study?

What are my rights if I take part in a clinical trial?

Taking part in the study or clinical trial is voluntary. You may choose not to take part or may leave the study at any time. Leaving the study will not result in any penalty or loss of benefits to which you are entitled.

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You will be told about new information that may affect your health, welfare or willingness to stay in the study.

Groups of experts at the national and local levels approve research studies before they begin. One of the most important groups is called an institutional review board (IRB).

The IRB's job is to review research studies and make sure they are run safely and fairly. All clinical trials should be reviewed by an IRB, which includes doctors, nurses and people from the community.

What are the costs of taking part in a clinical trial?

Taking part in the study may lead to added costs to you or your insurance company. You and/or your health plan/insurance provider (Medicare should be considered a health insurance provider) will need to pay for some or all of the costs of treating your cancer in the study.

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Some health plans will not pay these costs for people taking part in studies. Check with your health plan or insurance company to find out what they will pay for. Taking part in this study may or may not cost your insurance company more than the cost of getting regular cancer treatment. You or your insurance carrier will be responsible for the costs of clinic visits, any hospital admissions, laboratory tests, x-rays, scans, chemotherapy treatments, radiation treatments, and any other tests. Please ask your doctor about any added costs or insurance problems.

In the case of injury or illness resulting from the study, emergency medical treatment is available but will be provided at the usual charge. No funds have been set aside to compensate you in the event of injury.

For more information on clinical trials and insurance coverage, you can visit the National Cancer Institute's Web site. You can print a copy of the "Clinical Trials and Insurance Coverage" information from this Web site.

Will my medical information be kept private?

Efforts will be made to make sure that the personal information in your medical record will be kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from the study is published or presented at scientific meetings, your name and other personal information will not be used.

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A record of your progress will be kept in a confidential form at your hospital or doctor's office where you receive treatment. Organizations may inspect and/or copy your research and medical records (blood samples, x-rays, scans, pathology slides, etc.) for quality assurance, research, and data analysis.

If your record is used or given out for government purposes, it will be done under conditions that will protect your privacy to the fullest extent possible consistent with laws relating to public disclosure of information and law-enforcement responsibilities of the agency. These agencies may review the research to see that it is being done safely and correctly.

You authorize the use of clinical information contained in your records, but any publication which includes such information or data shall not review your name, show your picture or contain any other personally identifying information, except as otherwise required by law.

Are there different phases of clinical trials?

Cancer clinical trials include research at three different phases. Each phase answers different questions about the new treatment.

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    • Phase I trials are the first step in testing a new treatment in humans. In these studies, researchers look for the best way to give a new treatment (e.g., by mouth, IV drip, or injection? how many times a day?). They also try to find out if and how the treatment can be given safely (e.g., best dose?); and they watch for any harmful side effects. Because less is known about the possible risks and benefits in Phase I, these studies usually include only a limited number of patients who would not be helped by other known treatments.

  • Phase II trials focus on learning whether the new treatment has an anticancer effect (e.g., Does it shrink a tumor? improve blood test results?). As in Phase I, only a small number of people take part because of the risks and unknowns involved. Phase III trials compare the results of people taking the new treatment with results of people taking standard treatment (e.g., Which group has better survival rates? fewer side effects?). In most cases, studies move into Phase III testing only after a treatment shows promise in Phases I and II. Phase III trials may include hundreds of people around the country.