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What is a Clinical Trial?

In cancer research, a clinical trial is a study conducted with cancer patients, usually to evaluate a new treatment. Each study is designed to answer questions and to find new and better ways to help cancer patients.

The research usually begins in a laboratory and in animal studies. The best results of this research are then tried in patient studies. The research points out the new methods most likely to succeed. But this early research cannot predict exactly how a new treatment will work with patients.

A clinical trial is a process that helps researchers find new and better treatments. It is through this process that cancer care is advanced.

3women Why Would You Be Interested in a Clinical Trial?

Patients take part in clinical trials for many reasons. Usually, they hope for benefits for themselves. They may hope for a cure of the disease, a longer time to live or a way to feel better. Often they want to contribute to a research effort that may help others.

Although there is a chance that the results may be disappointing, the researchers have reason to believe that it will be as good as, or better than, current treatments.

The patients in a clinical trial are among the first to receive new research treatments before they are widely available. All patients in clinical trials are carefully monitored during a trial and followed up afterwards.

Are You Eligible for a Clinical Trial?

Each study enrolls patients with certain types and stages of cancer. Before any decision is made by you and your physician, your type of cancer will be diagnosed and "staged." Staging tells how far the disease has spread.

To Participate or Not to Participate

The decision is often not an easy one to make. It is very personal, and one that can only be made after you discuss the advantages and disadvantages with you physician and clinical trials nurse. Ask the questions you have about participating in the trial and carefully think about the answers. When your final decision is made, you need to feel that you have chosen what is best for you. Some women prefer the "tried and known" while others feel that they are getting an even better chance by taking newer drug or drug combination. Remember, no one has the right answer or an absolute answer for you—that is why it is called a "trial."

Questions to Ask about Clinical Trials

• Who is sponsoring the study? (Needs to be approved by reputable national group like the National Cancer Institute, a major teaching institution, or FDA.)
• What is the purpose of this study?
• What treatment(s) would you recommend if I decide not to participate in this study?
• If I participate in the study, what advantage might I have compared to standard recommended treatment?
• Will there be additional blood tests, biopsies or scans that I will be required to have if I enter this clinical trial? If so, do they create any additional risks?
• Does the trial require any hospitalization?
• How will participating in the trial affect my daily life compared to standard treatment? (Can I continue to work and pursue social activities?)
• Will I be able to take my regular medications (blood pressure, heart, and diabetic)?
• Will I be able to participate in any alternative or complementary therapies if I am in the trial (diets, herbs, vitamins, acupuncture, etc.)?
• How long will I be on the clinical trial?
• Where will I receive my treatments and be evaluated while on the trial (at local cancer center or another site)?
• Is the test drug/combination of drugs available outside the clinical trial? (Some drugs may be available to your physician outside the clinical trial.)
• How will the success of the treatment be evaluated (blood works, scans, etc.)?
• How much additional time will participating in the trial require over standard treatment?
• Will there be any extra expenses?
• Will my insurance company cover the cost of the trial?
• Will you (my personal healthcare team) be involved throughout the trial or will a new treatment team be in charge?
• Who will monitor my overall health while I participate in the trial?
• What type of follow-up will I have when the trial is completed?

Informed Consent

Your doctor or nurse will explain in detail the type and purpose of the trial. You will be given an informed consent form to read and sign. This form must include the expected benefits, other treatment options, assurance that your personal records will be kept confidential, provisions for compensation or injury, the negative aspects and a statement indicating that your participation is voluntary and you may withdraw at any time.

This consent form and ultimate decision can sometimes be overwhelming. Ask your healthcare provider to help you fully understand the study before signing the consent form. Signing the form means you understand the potential benefits and risks of the treatment and you want to participate. However, you are not legally bound to complete the trial. Participating in the trial does not prevent you from getting any additional medical care you may need. If you decide to participate in the trial, you will need to contact your insurance provider to ask if it covers any charges. Be sure the researchers are aware if your plan does not cover the costs of the experimental treatments.

Three Phases of Clinical Trials:

1. Phase I trials are designed to find out if a promising new therapy is worthy of further investigation. In the case of a new drug, researchers learn about its effects by gradually increasing the dosage and analyzing the responses, including side effects. Only a few people are recruited to participate and they usually have advanced cancer with no other treatment possibilities. These medications have been previously tested on animals.
2. Phase II studies determine the effect of a research treatment on various types of cancer. Each new phase of a clinical trial depends on and builds on information from an earlier phase. If a treatment has shown activity against cancer in Phase II, it moves to Phase III.
3. Phase III. In Phase III studies, the new treatment is directly compared to the old one.
4. Phase IV. If the new treatment is proven to work better than the standard treatment, the new research treatment is approved by the FDA and then becomes the standard treatment in patient care.

Please note that this entire process may take five to ten years before a new regimen is considered a standard of care.

How to Find a Clinical Trial

The most obvious place to start is with your oncologist. You can also contact an NCI designated clinical cancer center. Cancer Information Service (CIS), a program supported by the National Cancer Institute, can provide you with the names and numbers of centers near you (1-800-4-CANCER). When contacting CIS, request a Physician's Data Query (PDQ) search that will compile information about the latest nationwide cancer treatments for your specific type and stage of cancer. This information is updated monthly.

You can also access the PDQ here. Patient advocacy groups such as the National Alliance of Breast Cancer Organizations (NABCO) and the American Cancer Society (800-ACS-2345) also have patient information on participating in clinical trials and other relevant information on new trials.

For further information, contact Hahne Cancer Center at 814-375-3535.

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