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Frequently Asked Questions (FAQ) About Volunteering for Clinical TrialsChoosing to participate in a clinical trial is an important personal decision. The following FAQ provides detailed information about clinical trials and outlines specific questions you may want to ask the people who are conducting a clinical trial before deciding to participate. 1. What is a clinical trial?
Clinical trials are studies of drugs or other medical treatments in human beings that follow a defined study plan known as a protocol. These trials are sometimes called clinical studies or research studies or studies. 2. Who conducts clinical trials? Clinical trials are conducted by medical personnel, such as doctors and nurses. Doctors who conduct clinical trials are also called investigators. The clinical trial team may also include social workers and other health care professionals. The investigators will:
A protocol is a study plan for a clinical trial that is carefully designed to safeguard your health as well as answer specific medical research questions. A protocol details:
The protocol determines when you are seen by the investigators to monitor your health and to determine the safety and effectiveness of your treatment. 4. What are the types of clinical trials? Some clinical trials need healthy volunteers while others seek people with illnesses or conditions to be studied. This FAQ covers the latter kind of clinical trial. There are two major types of clinical trials or studies for people with specific illnesses or conditions:
In interventional trials, the investigators take an active role by administering a new intervention (a drug or medical device) and measuring the effect of that activity. In observational studies, the investigators take a passive role, only observing associations between the current treatments being used by participants and the health status of the participants. Learn more about the different types of clinical trials. 5. How do I qualify to participate in a clinical trial?
The guidelines are based on such factors as:
6. What happens during a clinical trial? It depends. In some clinical trials, there may be more tests and doctor visits than you would normally have for an illness or condition. Clinical trials work best when the protocol (study plan) is carefully followed and there is frequent contact between you and the investigators. 7. What should I know before participating in a clinical trial? To help you decide whether or not to participate, an investigator explains the details of the clinical trial. This is called informed consent. This means learning the key facts about a clinical trial before deciding whether or not to participate. It continues throughout the trial, so you always have updated information. The investigator will provide an informed consent document that includes details about the trial, such as:
You should know as much as possible about the clinical trial and feel comfortable asking the investigator questions about it. Then, you decide whether or not to sign the informed consent document. Informed consent is not a contract, and you may withdraw from the clinical trial at any time. 8. What should I ask the investigator about a clinical trial? The following questions might be helpful for you to discuss with the investigator. Some of the answers to these questions are found in the informed consent document.
9. How should I prepare for the initial meeting with the investigators? To prepare for a meeting with investigators, you should:
10. What are the benefits of participating in a clinical trial? Clinical trials that are well-designed and well-executed are the best approach for you to:
11. What are the risks of participating in a clinical trial? There are risks to clinical trials:
12. How is my safety protected? The same ethical and legal codes that apply to doctors also apply to clinical trials. In addition, most clinical research is regulated by governments, with built in safeguards to protect the participants. Every clinical trial in the United States 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 a clinical trial is ethical and the rights of participants are protected. Many countries have similar review boards and regulations. 13. What are side effects and adverse reactions? Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects will vary depending on the medication being studied. One of the goals of clinical trials is to evaluate experimental treatments for both immediate and long-term side effects. The investigator will be able to discuss this with you before you sign up for the clinical trial. 14. Can I continue to work with my primary health care provider while in a trial? Yes. Most clinical trials provide short-term treatments related to a designated illness or condition but do not provide extended or complete primary health care. In addition, by having your health care provider work with the investigators, you can ensure other medications or treatments will not conflict with the protocol. 15. Can I leave a clinical trial after it has begun? Yes. You may leave a clinical trial at any time for any reason. When withdrawing from the trial, you should let the research team know about it and the reasons for leaving the study. 16. What is a control or control group? A control is a base line against which the effects of the study treatment can be measured. It could be the existing standard treatment for the illness that the drug being studied is designed to treat, or it could be no treatment at all. For example, 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. It is very important that participants and investigators do not know which treatment the participant receives. A placebo, sometimes called a “sugar pill,” 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 experimental treatment's effectiveness. In some trials, people in the control group will receive a placebo instead of an active drug or experimental treatment. 18. Where do the ideas for trials come from? Ideas for clinical trials usually come from researchers who may work at pharmaceutical companies, universities, hospitals or in government programs. Researchers test new therapies or procedures in the laboratory and in other studies. The experimental treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about an experimental treatment, its risks and how well it may or may not work. 19. Who sponsors clinical trials? Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups and pharmaceutical companies, in addition to U.S. federal agencies. Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices or community clinics. 20. What are the different kinds of studies that are done in clinical trials? Treatment studies test experimental treatments, new combinations of drugs or new approaches to surgery or radiation therapy
21. What are the phases of clinical trials? Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
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