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PARCIPATING IN RESEARCH: FREQUENTLY ASKED QUESTIONS

What is a clinical study?
Why participate in a clinical study?
Who can participate in a clinical study?
What happens during a clinical study?
What is informed consent?
How should a potential participant prepare to meet with the research coordinator?
Does a participant continue to work with a primary health care provider while in a study?
What are side effects and adverse reactions?
What are the benefits and risks of participating in a clinical study?
How is the safety of the participant protected?
Can a participant leave a clinical study after it has begun?
Where do the ideas for studies come from?
Who sponsors clinical studies?
What is a protocol?
What is a placebo?
What is a control or control group?
What are the different types of clinical studies?
What are the phases of clinical studies?

What is a clinical study?
A clinical study is a research study designed to answer specific questions about vaccines, new therapies or new ways of using known treatments. Clinical studies (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical studies are the fastest and safest way to find treatments that work.

Why participate in a clinical study?
Participants in clinical studies can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

Who can participate in a clinical study?
All clinical studies have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical study are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical study, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical study, while others need healthy participants. 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.

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What happens during a clinical study?
The clinical study process depends on the kind of study being conducted (See What are the different types of clinical studies?) The clinical study team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the study, give specific instructions for participating in the study, monitor the participant carefully during the study, and stay in touch after the study is completed.

Some clinical studies involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of studies, the participant works with a research team. Clinical study participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

What is informed consent?
Informed consent is the process of learning the key facts about a clinical study before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the study explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the study at any time.

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How should a potential participant prepare to meet with the research coordinator?
It is a good idea to plan ahead and write down possible questions to ask. You should have a friend or relative come along for support and to hear the responses to the questions. In fact, most of the studies at the Memory and Aging Program require that participants have a caregiver who knows them well accompany them to all visits.

Does a participant continue to work with a primary health care provider while in a study?
Yes. Most clinical studies 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.

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.

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What are the benefits and risks of participating in a clinical study?
Benefits
Clinical studies that are well-designed and well-executed are the best treatment approach for eligible participants to:

Play an active role in their own health care.
Gain access to new research treatments before they are widely available.
Obtain expert medical care at leading health care facilities during the study.
Help others by contributing to medical research.
Risks

There are risks to clinical studies.

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

How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical studies. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The study follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical study progresses, researchers report the results of the study at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports (See Confidentiality Regarding study Participants).

Every clinical study 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 study 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 a participant leave a clinical study after it has begun?
Yes. A participant can leave a clinical study, at any time. When withdrawing from the study, the participant should let the research team know about it, and the reasons for leaving the study.

Where do the ideas for studies come from?
Ideas for clinical studies usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the treatments with the most promising laboratory results are moved into clinical studies. During a study, more and more information is gained about a new treatment, its risks and how well it may or may not work.

Who sponsors clinical studies?
Clinical studies 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 federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Studies can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.

What is a protocol?
A protocol is a study plan on which all clinical studies are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the study; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical study, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

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What is a placebo?
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical studies, 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 studies, 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 are the different types of clinical studies?
Treatment studies test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Prevention studies 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.
Screening studies test the best way to detect certain diseases or health conditions.

What are the phases of clinical studies?
Clinical studies are conducted in phases. The studies at each phase have a different purpose and help scientists answer different questions:
In Phase I studies, 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 studies, 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 studies, 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. It a drug or treatment is effective and safe in a Phase III study it may be approved for general use by the Food and Drug Administration (FDA).
Phase IV studies delineate additional information including the drug's risks, benefits, and optimal uses after a treatment is already available for general use.

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Information from clinicaltrials.gov/ct/info/resources

 

Memory and Aging Program
Butler Hospital
345 Blackstone Blvd.
Providence, RI 02906


401-455-6403
Fax: 401-455-6405
memorydisorder.org

 

 

Website: Thea Brennan-Krohn
email: theabk@yahoo.com