A clinical trial, in cancer research, is a study conducted with cancer patients for the purpose, most commonly, of evaluating a new treatment. Clinical trials are designed to answer scientific questions and to discover new and improved ways to treat and help cancer patients. Clinical trials are conducted to determine if a promising new treatment is effective and safe for patients and to determine the possible risks and benefits of the therapy. Current treatment protocols are commonly used as the basis for developing new and improved treatments.

When a diagnosis of breast cancer is made, what are the treatment options?

Scientific research to find better treatments for cancer starts with basic research in the laboratory (in vitro) and animal (in vivo) studies. The safest and best results of such research can then be translated to human studies with the hope of finding breakthroughs that will benefit patients. Patients are enrolled in clinical trials on a strictly voluntary basis after careful screening and with the patients' full consent. Patients participating in clinical trials are carefully monitored throughout the trial and are followed after the trial has ended. These patients become part of a network of clinical trials being conducted around the country run by teams of doctors and researchers. The researchers and doctors share their experiences and ideas to refine and monitor clinical trials.

There are a variety of reasons why patients choose to participate in clinical trials. Patients may be looking for a treatment to help prolong their lives after their cancer has not responded to treatment; they may be looking for a treatment that shows promise of less side effects so that they will feel better and have a better quality of life while undergoing treatment; and patients often choose to enter a clinical trial to contribute to research that may lead to a scientific breakthrough that will help other patients.

Patients may be exposed to health risks and drug side effects if they choose to participate in clinical trials. Also, because patients are receiving new treatment under investigation, not all of the potential risks, side effects and benefits are fully known or understood ahead of time.

Suggested questions to ask about clinical trials:

1. What is the purpose of the study?
2. What kinds of tests and treatments does the study involve (what and how are they performed/administered)?
3. What kind of long-term follow-up care is included in the study?
4. How will the study affect my daily life and routine?
5. How far will I have to travel to receive the treatment?
6. How often will I need to go in for the treatment?
7. How long will the study last?
8. What are the possible side effects and risks of the treatment?
9. What are the possible benefits of the treatment?
10. Will I need to be hospitalized, and, if so, how often and for how long?
11. In my case, what is likely to happen with or without this new treatment?
12. What might this new treatment do and what might the cancer do?
13. If I am harmed as a result of the study, what treatment will I be entitled to?
14. Are there other alternatives to this treatment and what are their advantages and disadvantages?
15. Are there standard treatments for my case and how does the study compare with them?
16. Will I incur any costs or will all of the treatment and follow-up care be free?

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