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What are clinical trials?
Clinical trials, also called cancer treatment or research studies, test new treatments in people with cancer. The goal of this research is to find better ways to treat cancer and help cancer patients. Clinical trials test many types of treatment such as new drugs, new approaches to surgery or radiation therapy, new combinations of treatments or new methods such as gene therapy. However, it is important to remember that, in most cases, the new treatment being tested has already shown promise of being an improvement over the current therapy.
Why are clinical trials important?
First, clinical trials contribute to knowledge and progress against cancer. If a new treatment proves effective in a study, it may become a new standard treatment that can help many patients. Many of today's most effective standard treatments are based on previous study results.
Second, the patients who take part may be helped personally by the treatment(s) they receive. They get up-to-date care from cancer experts, and they receive either a new treatment being tested or the best available standard treatment for their cancer. In the past, clinical trials were sometimes seen as a last resort for people who had no other treatment choices. Today, patients with common cancers often choose to receive their first treatment in a clinical trial.
Should I take part 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.
What is informed consent?
Informed consent is a process during which you learn key facts about a clinical study before you decide whether or not to join. These facts include details about the study approach and tests you may have, and the benefits and risks that could result. Don't be afraid to ask questions until you get all the facts you need to decide. This is an important decision, and you should feel at ease with the choice you make.
Signing a consent form does not mean you must stay in the study. You can change your mind and leave the study at any time you want - before the study starts or at any time during the study or follow-up period. If you decide to leave, you will have a chance to discuss other treatments and care with your physician.
How long is the study for?
The length of the study will vary. It will depend on the disease site, and the stage of disease. Some studies are specific in the length of time the patient is treated. There are other studies where the length of time a patient is on study will depend on the response the patient is showing.
What benefit is there for me to participate?
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.
- 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.
- 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.
You should discuss the benefits and drawbacks with your doctor and the people close to you.
What additional cost is there for me to participate?
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. If you are involved in a study with investigational drugs, those drugs are usually supplied through the study. Any procedure related solely to the research study will be explained to you by your physician.
Will my relationship with my doctor be affected if I elect not participate in the study?
Taking part in a research study is up to you. It may be only one of your treatment choices. Your doctor will discuss all your treatment options with you. If you decided not to participate in the study the decision will in no way affect your relationship with your physician.
What if after I start treatment I change my mind and want to stop participating in the study?
You may refuse to participate in a study at any time. Participation is voluntary and will not affect your relationship with your physician. If you choose to leave the study, you will have a chance to discuss other treatments and care with your doctor.
How will you I know if the study/investigational drug is working?
While you are on study, your doctor and nurse practitioner will be monitoring your health carefully. This means that you may have more tests and doctor visits than you would if you were not in the study. We will be reviewing your blood work and other tests, such as x-rays and scans to monitor your progress on the study.
Where can I find additional information about clinical trials?
You may call the NCI's Cancer Information Service at:
1-800-4 CANCER (1-800-422-6237)
or
TTY:
1-800-332-8615
Additional information about clinical trials can also be found at the following NCI websites:
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