Home > Clinical Trials > Clinical Trials FAQ Clinical Trials FAQ Choosing to participate in a clinical trial is an important personal decision. This FAQ will provide you with detailed information about clinical trials. In addition, it is often helpful to talk to your health care provider, family members, or friends about deciding to join a trial. AIDSinfo health information specialists are available by phone to help you identify clinical trials for which you may be eligible and to answer your questions. After you have identified some trial options, the next step is to contact the research staff and ask questions about specific trials. Table of Contents What is an HIV/AIDS clinical trial? What is a protocol? What are clinical trial phases? What protections are there for people who participate in clinical trials? What is informed consent? Who can participate in a clinical trial? Who sponsors clinical trials? What happens during a clinical trial? What is a placebo? What is a control or control group? What is a blinded study? What is a double-blind study? What are side effects and adverse reactions? What are the benefits and risks associated with clinical trials? What should I know before I join a clinical trial? How should I prepare for the meeting with the research coordinator or doctor? What questions should I ask? Should I continue working with my primary health care provider if I participate in a trial? Can I leave a clinical trial after it has begun? Will I be paid for participating in a clinical trial? How to find information about clinical trials on HIV and AIDS? What is an HIV/AIDS clinical trial? An HIV/AIDS clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) 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 treatments that work. Trials are also conducted to determine how HIV progresses and affects various parts of the body, and how it can be prevented. Ideas for HIV/AIDS clinical trials usually come from researchers. Once researchers test new therapies or procedures in the laboratory and get promising results, they begin planning Phase I clinical trials. New therapies are tested on people only after laboratory and animal studies show promising results. What is a protocol? All clinical trials are based on a set of rules called a protocol. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment. What are clinical trial phases? There are four types of clinical trials:
The government has strict guidelines and safeguards to protect people who choose to participate in clinical trials. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research. What is informed consent? Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to participate. These facts include:
It is also a good idea to take the consent documents home and discuss them with family members or friends. Talking about your options can help you to feel comfortable with your decision. If you decide to join the clinical trial, be sure to ask for a copy of the informed consent documents so you can review them at any time. Remember informed consent is more than signing a form. It is a process that continues through the study. You should feel free to ask the research team questions before, during, and after the study. Informed consent continues as long as you are in the study. Who can participate in a clinical trial? All clinical trials have guidelines about who can get into the program. Guidelines are based on such factors as age, type of disease, medical history, and current medical condition. Before you join a clinical trial, you must qualify for the study. Some research studies seek volunteers with illnesses or conditions to be studied in the clinical trial, while others need healthy volunteers. Healthy volunteers participate in Phase I trials, vaccine studies, and trials on research on preventive care for children or adults. The factors that allow you to participate in a clinical trial are called inclusion criteria and the factors that keep you from participating are called exclusion criteria. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study. Who sponsors clinical trials? Clinical trials are sponsored by government agencies, such as the National Institutes of Health (NIH); pharmaceutical companies; individual physician-investigators; healthcare institutions such as health maintenance organizations (HMOs); and organizations that develop medical devices or equipment. Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics. What happens during a clinical trial? The clinical trial process depends on the kind of trial you participate in. The team will include doctors and nurses as well as social workers and other health care professionals. They will check your health at the beginning of the trial, give you specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch with you after the study. Some clinical trials involve more tests and doctor visits than you would normally have for your illness or condition. For all types of trials, you will work with a research team. Your participation will be most successful if you follow the protocol carefully and stay in contact with the research staff. Some terms that will help you understand what happens in a trial are defined below. What is a placebo? A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment. What is a control or control group? A control is the 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 a standard treatment for the illness or a placebo. What is a blinded study? A blinded study is one in which participants do not know whether they are in the experimental or control group in a research study. Those in the experimental group get themedications or treatments being tested, while those in the control group get a standard treatment or no treatment. What is a double-blind study? A double-blind study is one in which neither the participants nor the study staff know which participants are receiving the experimental treatment and which ones are getting either a standard treatment or a placebo. These studies are performed so neither the patients' nor the doctors' expectations about the experimental drug can influence the outcome. What are side effects and adverse reactions? Side effects are any undesired actions or effects of drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects. What are the benefits and risks associated with clinical trials? There are both benefits and risks associated with HIV/AIDS clinical trials. By participating in a clinical trial, you can:
You should know as much as possible about the research study. It is important for you to feel very comfortable asking questions and the staff should answer them in a way you can understand. A list of sample questions appears below. How should I prepare for the meeting with the research coordinator or doctor?
Some questions you might ask about the research include:
Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but not extended or complete primary health care. In addition, by having your health care provider work with the research team, you can ensure that your other medications or treatments will not conflict with the clinical trial protocol. Can I leave a clinical trial after it has begun? Yes. You can leave a clinical trial at any time. If you plan to stop participating, let the research team know why you are leaving the study. Will I be paid for participating in a clinical trial? Some clinical trials will pay you for joining the trial, while others will not. In some programs, researchers will reimburse you for expenses associated with participatingin the research. Such expenses may include transportation costs, child care, meals, and accommodations. How to find information about clinical trials on HIV and AIDS? AIDSinfo has been established to provide free, up-to-date information on clinical trials that evaluate experimental drug and biological treatments for adults and children with HIV infection and AIDS. To find out more about AIDS clinical trials, call AIDSinfo toll free. Callers can speak with experienced health specialists who can answer questions concerning the clinical trial’s purpose, location, eligibility requirements, names and telephone numbers of the contact persons, and more. Bilingual specialists are available to talk with Spanish-speaking callers. To contact AIDSinfo toll free from the United States or Canada call: 1-800-HIV-0440 (1-800-448-0440) Fax: 1-301-519-6616 International: 1-301-519-0459 TTY: 1-888-480-3739 E-mail: ContactUs@AIDSinfo.nih.gov Web site: AIDSinfo.nih.gov In addition, the National Library of Medicine offers online computer access to information on AIDS clinical trials (free of charge) through its MEDLINE subscriber service and through the NLM and AIDSinfo World Wide Web sites. For more information about NLM, call: 1-800-638-8480 or 1-301-496-3147. Web site: www.nlm.nih.gov |
|||||
|