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Introduction To Clinical
Introduction To Clinical
You may have heard the term clinical trial and have questions about what a clinical
trial is and how it works.
The American Liver Foundation (ALF) is here to help. This guide contains
information on what a clinical trial is, who is involved, how the process works,
potential risks and benefits, and much more.
Learn as much as you can about clinical trials. Deciding to participate in a clinical trial
is a team effort! It involves talking to your doctor, your family and caregivers, and the
clinical trial team to see if it is an option for you.
The American Liver Foundation's mission is to facilitate, advocate, and promote education,
support, and research for the prevention, treatment, and cure of liver disease.
Table of Contents
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Clinical Trials Overview
Clinical Trials
A clinical trial is a medical research study conducted to find answers to health
questions.
Clinical trials are often conducted to evaluate new medications, a combination of
medications, or new ways to use current treatments. Clinical trials are also conducted
to evaluate new tests, equipment, and procedures for diagnosing and detecting health
conditions and to find vaccines to prevent illnesses.
Before an experimental treatment can be tested in a clinical trial, it must have shown
benefit in laboratory testing, animal research studies, or research in a small group of
humans. Clinical trials are required to follow the same ethical and legal guidelines as
standard medical practice to protect the safety of participants.
Every clinical trial in the United States must be approved and monitored by an
Institutional Review Board (IRB) to make sure the potential risks to participants are as
low as possible. Every institution that conducts clinical trials has an IRB. An IRB is a
committee of health care professionals and community members that do not have
connections to the specific clinical trial. The IRB committee allows for unbiased
decisions to be made about the clinical trial and patient safety.
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Clinical Trial Informed Consent
Informed consent is the process of learning about the clinical trial before deciding to
participate. Before someone can participate in a clinical trial they must review and
sign an informed consent form. As part of the informed consent process, participants
also will be able to review the trial protocol with the clinical trial team. A clinical
trial team consists of doctors, nurses, social workers, and other healthcare
professionals.
The informed consent form will include the following information:
o Clinical trial process, including tests that may be conducted
o Known risks and benefits of experimental treatment
o Length of clinical trial
o Clinical trial contact information
Even after signing the informed consent form, participants may choose to stop
participating in the clinical trial at any time.
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In some cases, research continues even after the FDA has approved a treatment. The
FDA can ask researchers to conduct a Phase 4 trial.
o Phase 4: collect information on experimental treatment’s long term safety and
effectiveness
Placebo: A placebo is an inactive pill, liquid or powder that looks like the experimental
treatment but has no effect on the body. In some clinical trials, experimental treatments
are compared with placebos to evaluate the effectiveness of the experimental treatment.
Control group: A control group consists of participants who receive either standard
treatment or a placebo and serves as a comparison group to measure the effectiveness of
the experimental treatment other participants are receiving. Participants are randomly
assigned to control or non-control groups.
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Frequently Asked Questions
What are the potential risks associated with participating in a clinical trial?
Potential risks associated with clinical trials include:
o Serious side effects
o Unsuccessful treatment outcome
o Ineligibility to participate in other trials
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Where can I find information about clinical trials in my area?
For information on clinical trials in your area:
o Search the National Institutes of Health’s clinical trials website:
http://clinicaltrials.gov
o Talk to your healthcare provider about clinical trials that you may be eligible
for
o Contact patient advocacy organizations for information on clinical trials in
your area
o Contact local medical institutions to learn about upcoming clinical trials
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Questions to Ask Your Healthcare Provider
1. Are clinical trials an option for me? If so, what types of clinical trials am I
eligible for?
2. Do you know of clinical trials that I can participate in that would be a good
option for me?
9. Do I follow up with you during the trial or the clinical trial team?
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Questions to Ask the Clinical Trial Team
5. How do the possible benefits and risks of this trial compare with my current
treatment?
6. What short and long term impact will this trial have on my day to day
activities?
11. Will I need to pay for any part of this clinical trial?
13. What happens if my condition gets worse during the clinical trial?
14. If for some reason I need to stop my participation in this clinical trial, how do
I communicate that and to whom?
16. Should I continue to see my own doctor during the clinical trial?
17. What type of long term follow up care is part of this study?
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Glossary
Clinical trial: A clinical trial is a medical research study conducted to find answers to
health questions. Clinical trials are often conducted to evaluate new medications,
combination of medications, or new ways to use current treatments. Clinical trials are
also conducted to evaluate new tests, equipment, and procedures for diagnosing and
detecting health conditions and to find vaccines to prevent illnesses.
Control group: A control group consists of participants who receive either standard
treatment or a placebo and serves as a comparison group to measure the effectiveness of
the experimental treatment other participants are receiving.
Double blind study: A double blind study is a clinical trial in which both the
participant and clinical trial team do not know which participants are receiving the
experimental treatment and which are receiving a placebo or standard treatment.
U.S. Food and Drug Administration (FDA): The Food and Drug Administration
(FDA) is a government agency responsible for ensuring the safety and effectiveness of
all medications, vaccines, medical equipment used for prevention, diagnosis, and
treatment.
Informed consent: Informed consent is the process of learning about the clinical trial
before deciding whether or not to participate. There is an informed consent form that
all participants are required to review and sign if they want to participate in the
clinical trial. The informed consent form will include information on the clinical trial
process, including tests that may be conducted, known risks and benefits of
experimental treatment, length of clinical trial, and clinical trial contact information.
Institutional Review Board (IRB): An Institution Review Board (IRB) is a committee
of health care professionals and community members, who review, approve, and
monitor clinical trials to make sure potential risks are as low as possible and that the
clinical trial follows ethical and legal codes for medical practice.
Placebo: A placebo is an inactive pill, liquid or powder that looks like the experimental
treatment but has no effect on the body. In some clinical trials, experimental treatments
are compared with placebos to evaluate the effectiveness of the experimental treatment.
Protocol: A protocol is the clinical trial plan that explains the purpose and process of
the trial. A protocol will include information such as who can participate, how many
people will participate, what the treatment plan involves, type and frequency of tests,
how the results will be measured, reasons why the clinical trial may be stopped,
reasons why the researchers may stop giving the experimental treatment to a
participant, known and likely side effects of the experimental treatment, and
potential benefits of the experimental treatment.
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Randomization: Randomization is a method used to randomly assign participants to
treatment and/or control groups.
Single blind study: A single blind study is a clinical trial in which either the
participant or the clinical trial team does not know if the participant is taking the
experimental treatment.
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Notes
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Notes
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