What is a clinical trial?
Why participate in a clinical trial?
What happens during a clinical trial?
What is informed consent?
What are the different types of clinical trials?
What is a protocol?
What is a placebo?
What is a control or control group?
What is a phase 1 study?
What is a phase 2 study?
What is a phase 3 study?
How would I contact the Clinical Research office
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| What is a clinical trial? |
| Clinical trials, also known as clinical studies, are research that assist in answering specific questions about vaccines, new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find new treatments. |
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| Why participate in a clinical trial? |
| By participating in the clinical trial you will play a more active role in your own health care, may gain access to new research treatments before they are widely available, and help others by contributing to medical research. |
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| What happens during a clinical trial? |
| The clinical trial process depends on the type of protocol. The clinical trial team includes doctors, nurses, and other healthcare professionals. The team will evaluate your health at the beginning of the trial, and stay in touch after the trial is completed. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff. |
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| What is informed consent? |
| Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. To help you decide whether or not to participate, the doctors and nurses involved in the clinical trial will explain the details of the study. If you decide to participate, you will be asked to sign a consent form. You may take this form home and discuss it with your family and friends before making your decision. Don't be afraid to ask questions until you get all the facts you need. Informed consent is a continuing process throughout the study which will provide you with any new information. Informed consent is not a contract, and you may leave the study at any time- before the study starts or at any time during the study or follow-up period. |
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| What are the different types of clinical trials? |
| Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes. Screening trials test the way best to detect certain diseases or health conditions. Quality of life trials explore ways to improve comfort and quality of life for individuals with a chronic illness. |
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| What is a protocol? |
| A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes who may participate, the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, you will follow a protocol and will be seen regularly by the research staff to monitor your health and to determine the safety and effectiveness of your treatment. |
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| What is a placebo? |
| A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are sometimes compared with placebos to assess the treatment's effectiveness. In some studies, participants in the control group will receive a placebo instead of an active drug or treatment. |
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| What is a control or control group? |
| A control is a standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either the standard treatment for the illness or a placebo. |
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| What is a phase 1 study? |
| Phase 1 studies are concerned with assessing the drug's safety. This initial phase of testing is done in a small number of human, healthy volunteers (20 to 100), who are usually paid for participating in the study. The study is designed to determine what happens to the drug in the human body—how it is absorbed, metabolized, and excreted. A phase 1 study will investigate side effects that occur as dosage levels are increased. |
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| What is a phase 2 study? |
| Once a drug has been shown to be safe, it must be tested for efficacy. Most phase 2 studies are randomized trials. One group of patients will receive the experimental drug, while a second control group will receive a standard treatment or placebo. Often these studies are "blinded"--neither the patients nor the researchers know who is getting the experimental drug. In this manner, the study can provide the pharmaceutical company and the FDA comparative information about the relative safety of the new drug, and its effectiveness. |
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| What is a phase 3 study? |
| In a phase 3 study, a drug is tested in several hundred to several thousand patients. This large-scale testing provides the pharmaceutical company and the FDA with a more thorough understanding of the drug's effectiveness, benefits, and the range of possible adverse reactions. Most phase 3 studies are randomized and blinded trials. Once a phase 3 study is successfully completed, a pharmaceutical company can request FDA approval for marketing the drug |
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| How would I contact the Clinical Research office? |
| You can reach the Clinical Research nurse by calling (561) 366-4128. |
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