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| What are clinical trials ? |
| How are clinical trials conducted? |
| How can I find clinical trials? |
| Should I consider a clinical trial? |
| Will I be treated like a guinea pig? |
| Who pays for treatment in a clinical trial? |
| Will I be given a placebo? |
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| What are clinical trials? |
| Clinical trials are studies that test new and promising ways to treat cancer. Clinical trial research is the process by which new treatments are approved by the FDA (Food and Drug Administration) for use in the general public. Before a medication or procedure can be FDA approved, it must be tested to make sure that it is safe and effective. There are hundreds of trials being conducted throughout the country. When you are discussing your treatment plan with your doctor, ask about any clinical trial that may be an option for you. |
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| How are clinical trials conducted? |
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Phase I trials are the first human trials for a new treatment and are usually limited to a small number of people (usually fewer than 20). The goal of a Phase I trial is to find the highest dose and the best way to give a new therapy without undesirable side effects.
Phase II trials test whether a new therapy is effective against particular cancers. Phase II trials are open to more patients than Phase I trials, about 25 to 100 patients. In Phase II trials, doctors look for side effects and to see whether the drug actually works against particular types of cancer cells in humans.
Phase III trials test whether the new treatment kills more cancer than a currently approved standard treatment. Phase III clinical trials are open to many people, usually hundreds. The studies are conducted throughout the nation, and some are international. If a treatment is found to be safe and effective, the research is sent to the FDA for review. The FDA decides whether the new treatment can be used in the general public.
Phase IV trials study treatments already approved by the FDA to find the best way to use the new treatment. Patients do not need to be in a study to receive the new drug, since it is FDA approved, but can choose to participate.
Randomized clinical trials assign patients to different arms of a study. Study arms are the different treatment plans within the study. Some clinical trials are designed as double-blind, which means you and your doctor will not know which treatment arm you are on. Double-blind studies are done to make the study as fair as possible. If you are participating in a clinical trial you will be told whether it is randomized or double-blind.
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| How can I find clinical trials? |
| The National Institutes of Health provides a listing of all NCI (National Cancer Institute) funded clinical trials. You can research clinical trials yourself on the National Cancer Institutes’s clinical trials website. Some trials are open nationally and some are open only in specific states with a particular institution. Through its affiliation with the Seattle Cancer Care Alliance (the parent organization of the University of Washington and the Fred Hutchinson Cancer Research Center), Southwest Oncology Group (SWOG ), and CCOP (Community Clinical Oncology Program), Cascade Cancer Center has expanded access to both national and local clinical trials. |
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| Should I consider a clinical trial? |
Over the years, thousands of people have benefited from clinical trials. Some people have extended their lives by participating in clinical trials. Sometimes people in studies get promising medical treatments that would not be available to them by any other means. However, there are risks and possible side effects to consider, and no one knows exactly how a new treatment will work. Patients do not always respond in a positive way to a new treatment. It is up to you and your doctor to decide if a clinical trial is right for you. Patients who are interested in taking part go through a process called a screening to see if they meet certain criteria. These criteria define who is eligible to enroll in a trial. If you are eligible and your doctor thinks it is in your best interest, you will be given the option of trial participation. Your participation in a clinical trial is completely voluntary. You will not be placed in a clinical trial without your informed consent.
Before you make that decision to participate, a research coordinator will talk with you about the study. You will be given all the information available about the study, including likely risks and benefits. If you agree to participate, you will be asked to sign an informed consent. The informed consent is a document that outlines everything about the study. Signing the informed consent means you are saying yes to participating in the study. You will receive the same high quality care as those patients who are not participating in a clinical trial. If you change your mind, you are free to voluntarily withdraw from study participation at any time and for any reason, with no impact on the quality of care you receive. |
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| Will I be treated like a guinea pig? |
Clinical trials are the final phase of a long process of research. New approaches to cancer treatment come from research centers across the country where scientists first develop and test new ideas. If a new idea seems promising, it will be tested on laboratory animals first, to see if it has any harmful effects. If the treatment shows potential, researchers then apply for approval to test on humans. Not all treatments that work well in the lab work well on people.
When you are part of a clinical trial, you are participating in a research study. Keep in mind that although these treatments have shown promise in the laboratory setting and are believed to be better than existing treatments, they have not been approved by the Food and Drug Administration (FDA). You will be monitored carefully. Your doctor will only recommend treatment that he or she believes is right for you. |
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| Who pays for treatment in a clinical trial? |
| A drug company or a governmental agency usually funds clinical trials. These organizations are responsible for paying for any extra tests, procedures, or medications that are needed by the study above and beyond those needed for standard treatment. Your insurance will be billed for the cost of standard treatment. |
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| Will I be given a placebo? |
| Although patient’s worry about getting a placebo, sometimes called a sugar pill, the truth is that using only a placebo is not an accepted practice in cancer clinical trials. It simply would not be ethical to give only a placebo to a patient when treatments are available. Sometimes placebos are used, but not as a replacement for cancer treatment. When placebos are part of a study they are usually given with standard cancer drugs. Rest assured that if a placebo is part of your study design, you will be told, and it will be your decision whether or not to participate. |
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