Frequently Asked Questions about Clinical Trials
- What is a clinical trial?
- Who sponsors clinical trials?
- What are the phases of a clinical trial?
- Who can participate in a clinical trial?
- How can I benefit from participating in a clinical trial?
- What are the risks of participating in a clinical trial?
- What protections are in place when I participate in a clinical trial?
- What is informed consent?
- What should I know before I join a clinical trial?
- What Questions should I ask before I agree to participate in a clinical trial?
- How can I find out if I'm eligible for a clinical trial?
- What is a clinical trial visit like?
- Where can I find out more about clinical trials?
What is a Clinical Trial?
A clinical trial (also called “medical research”) is a research study in human volunteers to answer specific health questions. The best way to scientifically evaluate the effectiveness of a treatment is to conduct a clinical trial. Some clinical trials are used to determine whether new drugs, devices, or therapies are both safe and effective. Other clinical trials compare the best known standard therapy with a newer therapy to see if one produces a better result and/or causes fewer side effects than the other. Testing is performed on people only after laboratory and animal studies show promising results.
Clinical trials are conducted according to a plan, called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to follow the plan set out by the protocol.
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Who sponsors clinical trials?
Clinical trials can be sponsored by a number of different organizations: government agencies, such as the National Institutes of Health (NIH); pharmaceutical companies; individual physician-investigators; and health care institutions. The sponsor of a clinical trial funds the clinical trial and designs its protocol.
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What are the phases of a clinical trial?
Most clinical trials are carried out in steps called phases. Each phase is designed to answer a different question about the drug or disease being studied. Clinical trials of experimental drugs proceed through four phases:
- Phase I clinical trials are short-term studies in which researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- Phase II clinical trials evaluate the effectiveness of a treatment for a particular disease or condition and involve a larger group of people.
- Phase III clinical trials involve giving the experimental treatment to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. This large-scale testing often lasts several years and provides the manufacturer and the FDA with a more thorough understanding of the drug's safety, efficacy, and range of possible reactions. Once Phase III is successfully completed, a pharmaceutical company can request FDA approval for marketing the drug.
- Phase IV studies are done after the drug or treatment has been approved by the FDA. The pharmaceutical companies have several objectives in this late phase of testing: 1) to compare the drug with other drugs already on the market, 2) to monitor the drug's long-term safety, effectiveness, and impact on a patient's quality of life, and 3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. These studies may also involve different populations than those in which the drug was originally tested.
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Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate, including age, type of disease, medical history, and current medical condition. Before you join a clinical trial, you must qualify for the study.
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. The main purposes of these criteria are to identify appropriate participants and to keep the trials as safe as possible. The criteria also help ensure that the researchers will be able to answer the questions they plan to study.
It is important to understand that the inclusion and exclusion criteria are not used to reject people personally, only to uphold the safety and integrity of the research study.
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How can I benefit from participating in a clinical trial?
There are several reasons people take part in research studies.
Often it gives you a chance to access a medicine or procedure that is not available on the market. In these cases, you should remember that the study is being performed to find out more information about the safety and efficacy of the drug or procedure.
Also, diagnostic tests are performed to closely monitor your safety and to reduce risks. The process of collecting information for a study may allow your doctor to find out more about your disease, which may allow you to benefit from better treatment after you have completed the trial.
Perhaps most importantly, as a participant in a research study, you are contributing to scientific knowledge, and the information gathered will be of help to other patients with the same condition in the future. Many people derive satisfaction from knowing that they are part of the effort to reduce the suffering of other people.
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What are the risks of participating in a clinical trial?
The risks associated with participation in a clinical trial may include:
- side effects from medications or tests,
- treatment not being effective for you,
- the possible inconvenience of multiple trips to the study site.
Specific risks and benefits for each study are always described in the studies' informed consent form .
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What protections are in place when I participate in a clinical trial?
Doctors and other health professionals run clinical trials according to strict rules established by the Food and Drug Administration (FDA). The established rules ensure that if you agree to participate in a study, you will be treated as safely as possible.
Also, every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB). An IRB is an independent committee of health care professionals and other experts from the institution where the clinical trial takes place, as well as members of the local community. The sole purpose of an IRB is to protect the rights and welfare of research subjects. The board scrutinizes all trial activities including recruitment, informed consent, advertising, and potential risks.
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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.
If you are considering participating in a study, the research staff will give you informed consent documents that contain details about the study. This information should be written so that you can understand it. Since joining a clinical trial is an important decision, you should ask the research team any questions you may have about the study or your participation before you make a decision. You may also want to discuss participation with another doctor, a family member or friend. If you decide to participate in a trial, you must sign the informed consent form, showing that you have been given this information and that you understand it.
The informed consent form is NOT a contract and you can leave the study at any time, without penalty, for any reason.
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What should I know before I join a clinical trial?
You should know as much as possible about the research study. The informed consent will explain the details of the study. It is important for you to feel comfortable asking questions to the research staff about anything you do not understand or anything you would like more information about.
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What questions should I ask before I agree to participate in a clinical trial?
- Why is the research being done?
- What will be done to me as part of the research?
- How will I benefit from the research?
- What are the side effects or risks to me?
- What will the researcher do with my personal health information?
- Will the research cost me anything?
- Who pays if I am injured in the study?
- How long will the study last?
- What happens if I decide to leave the study early?
- What other options do I have?
- Who should I call if I have a question about the research?
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How can I find out if I am eligible for a clinical trial?
Each trial has certain requirements for participation outlined in the research protocol.
First, you must indicate that you are interested in participating in a clinical trial, you can do this by contacting your doctor, or the study’s contact person, either by phone or by email; this information generally is available on this website.
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What is a study visit like?
While the exact processes vary with each study, there are certain aspects common to all clinical trials that you should expect to encounter. The clinical research team conducting the study will include doctors and nurses and may include social workers, research coordinators and other health care professionals. They check your health at the beginning of the trial, give specific instructions for participating in the trial, monitor you carefully during the trial, and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than you might normally have for an illness or condition.
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Where can I find out more about clinical trials?
For trials at UT Southwestern and its affiliated institutions, including the University Hospitals (St. Paul and Zale Lipshy), Parkland Memorial Hospital, Children’s Medical Center, and the outpatient clinics, click here.
If you do not live in the Dallas-Fort Worth area, or if you would like more information about finding clinical trials, you may want to search the following websites:
For cancer, call 1-800-4-CANCER (1-800-422-6237) or visit this World Wide Website: cancertrials.nci.nih.gov/
For AIDS and HIV, call 1-800-TRIALS-A (1-800-874-2572) or visit this World Wide Website: www.actis.org
For general information about clinical trials, call FDA's Office of Special Health Issues at 301-827-4460 or visit this World Wide Website: www.fda.gov/oashi/home.html
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