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 Topics
| Frequently Asked Questions about Clinical TrialsWelcome to the Clinical Trials Office information page. Here you will find information on clinical trials: what they are, who can participate, and how they work.
A clinical trial is a carefully designed research study performed by physicians and other health professionals to help determine if a treatment (a medication, device, procedure, or method) is safe and effective. Clinical trials are an important step in the process of making a newly discovered treatment available to the general public. Many of today's most effective treatments are the direct result of knowledge gained through clinical trials. What are the Phases of Clinical Trials? Most discoveries of new treatments are the result of laboratory experiments. When researchers are ready to evaluate a new treatment in people, they carefully design clinical trials to test the treatment's effectiveness, its safety, and its side effects. Clinical trials follow an orderly progression of steps or phases to take the medication or other type of treatment from discovery to approval by the Food and Drug Administration (FDA). The very first trials to evaluate a new treatment may involve people without the illness or condition (healthy volunteers), or they may involve those who have the condition. Phase I clinical trials evaluate how a new treatment should be given (for example, orally or by injection), how often, and in what dose. A phase II trial, which involves people with a particular illness or condition, provides preliminary information about the benefit and safety of the new treatment. These trials are designed to compare the effectiveness and safety of the new medication or treatment with treatments already available for general use. Patients participating in Phase III trials are likely to be assigned by chance (randomized) to receive one of the following:
Most of these trials are designed so that neither the participants nor the researchers know which treatment is being given to a particular individual. This is done so that the effects of the treatment are reported fairly. Phase III trials involve hundreds or thousands of patients nationwide or even worldwide. If the results of a Phase III trial are favorable for the new treatment, then FDA approval will be sought. Once aproved by the FDA, a treatment will be available to the general public. At times, even after FDA approval, additional information is needed on the effectivness or the safety of a new treatment. If so, a phase IV clinical trial is conducted to provide such information. Other supportive care, prevention, and screening trials are not done in phases, but instead compare groups of people using another strategy (counseling, behavior changes, detection method) with those who do not. What is a Clinical Trial Protocol? Clinical trials follow strict scientific guidelines. These guidelines deal with many areas, including the study's design, who can be in the study, and the kind of information people must be given when they are deciding whether to participate. Every trial has a chief investigator, who is usually a doctor. The investigator follows a study action plan, called a protocol. This plan explains what the trial will do, how, and why. For example, it states:
Every research center which takes part in the trial uses the same protocol. This assures that information from all centers can be combined and compared. Who Can Participate in a Trial? Clinical trials enroll people who are alike in certain ways depending on the study's purpose. Every protocol identifies some specific characteristics that the people should have in order to participate in the study. These characteristics are called eligibility criteria. They may include the type of disease or condition and its stage, as well as the age and general health of the participants. Eligibility criteria are a key part of medical research. They help assure that the study results answer the research question. They also help doctors identify who will benefit in the future from the approach being studied. For example, in cancer prevention studies, a new medication may work for people with one type of risk factor but not for those with another. Eligibility criteria also help assure the safety of participants by protecting them from known risks. For example, some medications can only be given safely if a person has normal kidneys or liver. So, persons with kidney or liver problems may be excluded from participating. Those who are interested in participating in a clinical trial should visit our list of open clinical trials. What are the Benefits, Disadvantages, and Risks of Participating in a Clinical Trial? The benefits, disadvantages, and risks of a clinical trial are listed in the consent form which must be read and signed by each participant. Also, a member of the research team must explain all of these aspects of the trial. Benefits — During the time of participation in a clinical trial, patients may benefit from a research medication or treatment long before it is available to the general public. Throughout the trial, patients receive careful medical attention. There might be extra examinations and tests which will not be billed to patients or their insurance companies. Also, some patients consider it a benefit that they are contributing to medical science. Disadvantages — The main disadvantage to participating in a clinical trial is the time commitment. During the trial, additional office visits or laboratory tests are sometimes needed. Although the patient is not required to pay for these extra services, they often require time away from home or job. However, some trials do provide payment for travel-related expenses. In some clinical trials patients must stop taking their regular treatment/medication before the trial begins. There may be a short time of increased discomfort until the new treatment begins to work. However, sometimes the study treatment does not work for a particular patient. Risks — As with other treatments, those used in clinical trials may cause side effects that vary from person to person. Because the research treatments being tested in a clinical trial may be relatively new, it is possible that unknown side effects could occur. The risks and possible side effects specific to the clinical trial must be listed in the consent form and discussed by the research team with each participant. How are Trial Participants Protected? Clinical trials have several built-in safeguards to help protect the people who participate. One or more review groups must approve the protocol for every study prior to enrolling patients. All clinical trials must be approved by the FDA. On a local level, the hospital or clinic has a committee, the Institutional Review Board (IRB), which oversees all clinical trials in the healthcare facility. The IRB, which includes doctors, other health care providers, and members of the community, review every clinical trial at a particular hospital or clinic. IRB members do not have any personal interest in the results of the study. They serve as neutral reviewers. The IRB has the following functions aimed at protecting research participants:
Most of all, participation in a clinical trial is voluntary. A person who agrees to participate can choose to stop participation at any time. Where can I find out more
about a medical condition? There are several organizations across the United States that perform clinical trials, have information on clinical trials current being performed, or have information on how clinical trials are being used to treat specific diseases. For more information on any of these organizations, check out their web sites.
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