What is a clinical trial? What happens during a clinical trial? What is protocol? What are the benefits of being in a clinical trial? What are the risks of being in a clinical trial? Who pays for clinical trials? Who can take part in a clinical trial? What is informed consent? How is the participant's safety protected? Can participants quit a clinical trial after it has started? What should people consider before participating? How should participants get ready? What are the different types? What is control or control group? What is a placebo? What are side effects and adverse reactions? What are the phases of clinical trials? Do participants still see thier primary care doctor?

This information was adapted from the National Institutes of Health Website

What is a clinical trial?
A clinical trial is a research study that tests a new medical treatment or a new way of using an existing treatment to see if it will be a better way prevent, screen for, diagnose or treat a disease. People volunteer to be in a clinical trial and to answer specific questions about their health. Carefully conducted clinical trials are the fastest and safest way to find treatments that improve people’s health.
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What happens during a clinical trial?
A participant in a clinical trial works with a research team that includes doctors and nurses as well as social workers and other health care professionals. The team checks the participant’s health at the beginning of the trial, gives specific instructions for taking part in the trial, observes the participant carefully during the trial, and stays in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than is usual for an illness or condition.

Participation in a clinical trial is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
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What is a protocol?
A protocol is the study plan on which the clinical trial is based. The plan is carefully designed to protect the health of the participants as well as to answer specific research questions. A protocol describes what types of people may take part in the trial; the schedule of tests, procedures, medications, and dosages; and the how long the study will last. During a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of the treatment.
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What are the benefits of being in a clinical trial?
Participants in clinical trials play a more active role in their own health care, have access to new research treatments before they are widely available, get expert medical care at leading health care facilities, and help others by contributing to medical research.
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What are the risks of being in a clinical trial?
There are risks to clinical trials:

• The treatment may have unpleasant, serious or even life-threatening side effects.
• The treatment may not be effective for the participant.
• The protocol may require more of the participant’s time and attention than a different treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

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Who pays for clinical trials?
Clinical trials are sponsored or funded by many organizations or individuals such as physicians, medical institutions, foundations, voluntary groups and pharmaceutical companies. They are also sponsored by government agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD) and the Department of Veteran's Affairs (VA). Trials can take place in many different locations such as hospitals, universities, doctors' offices and community clinics.
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Who can take part in a clinical trial?
All clinical trials have rules about who can and cannot be in the trial. This is an important principle of medical research that helps researchers answer the questions they plan to study. The rules that allow someone to participate in a clinical trial are called "inclusion criteria" and those that keep someone out of a trial are called "exclusion criteria." They are based on such factors as a person’s age, gender, the kind of disease he or she has and how serious it is, what treatments he or she received before being in the trial, and whether that person has other medical problems.

It is important to understand that inclusion and exclusion criteria are not used to reject people personally. They are used to identify the people who are the most appropriate for that trial and to keep them safe. A participant must qualify for a clinical trial before joining it. Some research studies need people who have the disease or condition that will be investigated in the clinical trial, while other trials need people who are healthy.
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What is informed consent?
Informed consent is learning about and understanding what happens during the clinical trial before deciding whether or not to be in it. To help someone make that decision, if they qualify, the doctors and nurses involved in the trial explain the details of the study. If the participant does not speak English well, he or she can get help with translation. The research team provides an informed consent document that includes details about the study such as its purpose, how long it will last, what procedures are required, and the names of key contacts. The informed consent document also explains the potential risks and benefits of the trial. Participants also will get information about how things are going during the trial.
The participant then decides whether or not to sign the document. Informed consent is not a contract, and you may leave the clinical trial at any time.
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How is the participant’s safety protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is regulated by the federal government with built-in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial goes forward, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. The names of people taking part in the trial remain secret and are not mentioned in these reports.

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 who make sure 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.
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Can participants quit a clinical trial after it has started?
Yes. Participants can leave a clinical trial at any time. If they leave the trial, they must let the research team know and tell them why they are leaving the study.
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What should people consider before participating in a trial?
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about the trial, the kind of care they will receive during the trial and the cost of the trial.

It might be helpful for anyone who is considering taking part in a clinical trial to discuss the following questions with the research team before making a decision. Some of the answers to these questions are found in the informed consent document.

• What is the study for?
• Who is going to be in the study?
• Why do researchers think the new treatment being tested will work? Has it been tested before?
• What kinds of tests and treatments are involved?
• Are the possible risks, side effects, and benefits in the study different from my current treatment?
• How might this trial affect my daily life?
• How long will the trial last?
• Will I have to go into the hospital?
• Who will pay for the treatment?
• Will I get money back for other expenses
• What type of long-term follow-up care is part of this study?
• How will I know that the treatment is working? Will I get the results of the trials?
• Who will be in charge of my care?
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How should participants get ready for the meeting with the research coordinator or doctor?

• Write down their questions.
• Ask a friend or family member to go with them for support and to hear the answers to their questions.
• Bring a tape recorder, tape the meeting and listen to it later.
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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 a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
• Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
• Screening trials test the best way to detect certain diseases or health conditions.
• Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for people with a chronic illness.
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What is a control or control group?
A control is the standard that the research team uses to compare and evaluate the results of the experiments done in the trial. 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.
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What is a placebo?
A placebo is a pill, liquid, or powder that looks like medicine but has no medicine in it and has no effect on people. It is commonly called a “sugar pill.” 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 receive a placebo instead of an active drug or treatment.
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What are side effects and adverse reactions?
Side effects are any undesired actions or effects of a 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.
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What are the phases of clinical trials?
Clinical trials are conducted in phases. Each phase of a trial has a different purpose and helps scientists answer different questions:

• In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
• In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
• In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) 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.
• Phase IV trials studies are done after a drug has been approved that gather additional information including the drug's risks, benefits, and optimal use.
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Do participants still see their primary doctor while they are 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 the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

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