Should I Enroll in a Clinical Trial?

This is a question only you, those close to you, and your health professionals can answer together. Learning you have cancer and deciding what to do about it is often overwhelming. This section has information you can use in thinking about your choices and making your decision.

Clinical Trials: Weighing the Pros and Cons

While a clinical trial is a good choice for some people, this treatment option has possible benefits and drawbacks. Here are some factors to consider. You may want to discuss them with your doctor and the people close to you.

Possible Benefits

Clinical trials offer high-quality cancer care. If you are in a study and do not receive the new treatment being tested, you will receive the best standard treatment. This may be as good as, or better than, the new approach. If a new treatment approach is proven to work and you are taking it, you may be among the first to benefit. By looking at the pros and cons of clinical trials and your other treatment choices, you are taking an active role in a decision that affects your life. You have the chance to help others and improve cancer treatment.

Possible Drawbacks

New treatments under study are not always better than, or even as good as, standard care. They may have side effects that doctors do not expect or that are worse than those of standard treatment. Even if a new treatment has benefits, it may not work for you. Even standard treatments, proven effective for many people, do not help everyone.

If you receive standard treatment instead of the new treatment being tested, it may not be as effective as the new approach. Health insurance and managed care providers do not always cover all patient care costs in a study. What they cover varies by plan and by study. To find out in advance what costs are likely to be paid in your case, talk to a doctor, nurse or social worker from the study.

Your Rights, Your Protections

–Before and during a cancer treatment study, you have a number of rights. Knowing these can help protect you from harm.

–Taking part in a treatment study is up to you. It may be only one of your treatment choices. Talk with your doctor. Together, you can make the best choice for you.

–If you do enter a study, doctors and nurses will follow your response to treatment carefully throughout the research.

–If researchers learn that a treatment harms you, you will be taken off the study right away. You may then receive other treatment from your own doctor.

–You have the right to leave a study at any time.

One of your key rights is the right to informed consent. Informed consent means that you must be given all the facts about a study before you decide to take part. This includes details about the treatments and tests you may receive and the possible benefits and risks they may have. The doctor or nurse will give you an informed consent form that goes over key facts. If you agree to take part in the study, you will be asked to sign this informed consent form.

The informed consent process continues throughout the study. For instance, you will be told of any new findings regarding your clinical trial, such as new risks. You may be asked to sign a new consent form if you want to stay in the study.

Signing a consent form does not mean you must stay in the study. In fact, you can leave at any time. If you choose to leave the study, you will have the chance to discuss other treatments and care with your own doctor or a doctor from the study.

Questions You Should Ask

Finding answers and making choices may be hard for people with cancer and those who care about them. It is important to discuss your treatment choices with your doctor, a cancer specialist (an oncologist) to whom your doctor may refer you, and the staff of any clinical trial you consider entering.

Ask questions about the information you receive during the informed consent process and about any other issues that concern you. Getting answers can help you work better with the doctor. You may want to take a friend or relative along when you talk to the doctor. It also may help to write down your questions and the answers you receive, or bring a tape recorder to record what is said. No question about your care is foolish. It is very important to understand your choices.

Here are some questions you may want to ask:

The Study

–What is the purpose of the study? In what phase is this study?

–Why do researchers believe the new treatment being tested may be effective? Has it been tested before?

–Who sponsors the study, and who has reviewed and approved it?

–How are the study data and patient safety being checked?

–When and where will study results and information go? Possible Risks and Benefits

–What are the possible short- and long-term risks, side effects, and benefits to me?

–Are there standard treatments for my type of cancer?

–How do the possible risks, side effects, and benefits in the study compare with standard treatment?


Your Care

Where will my treatment take place? Will I have to be in the hospital? If so, how often and for how long?

–How will I know if the treatment is working?

–Will I be able to see my own doctor? Who will be in charge of my care?

Personal Issues

How could the study affect my daily life?

–Can you put me in touch with other people who are in this study?

–What support is there for me and my family in the community?

Cost Issues

Will I have to pay for any treatment, tests, or other charges?

–What is my health insurance likely to cover?

–Who can help answer any questions from my insurance company or managed care plan?

For questions regarding cancer, you may contact Cancer Answers and speak with an Oncology Nurse, 1-800-UAB-0933.

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