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What is a clinical research trial?
A clinical trial is a research program conducted with
patients to evaluate a new medical treatment, drug or
device. The purpose of clinical trials is to find new
and improved methods of treating different diseases
and special conditions.
There are four phases of a clinical trial:
- Phase I: a new research treatment is given to a
small number of participants. The purpose is to determine
the best way to give the new treatment and how much
of it can be given safely.
- Phase II: clinical trials determine the effect of
a research treatment on a particular disease or condition.
- Phase III: clinical trials compare the new treatment
with the standard treatment
- Phase IV: clinical trials apply the new treatment
to patient care.
Who can participate?
Every clinical trial is designed to look at a specific
set of patients. Each study enrolls patients with certain
conditions and symptoms. If you fit the guidelines,
you may be able to participate. In some instances, you
may be asked to undergo certain tests to make sure you
are appropriate for the study.
What are the advantages?
During a clinical trial, physicians use the best treatment
available as a standard to evaluate new treatments.
The new treatments are at least as effective or possibly
more effective than standard treatments. If you participate:
- You may receive a new treatment before it is widely
available to the public
- You can provide researchers with the information
they need to continue developing new procedures and
treatment methods
- Your treatment costs may be decreased (many of the
tests and physician visits that are directly related
to the study are paid for the company or agency conducting
the clinical trial).
Could there be side effects?
Yes. Side effects will depend on the type of treatment
and the patient's condition. All of the risks and side
effects of the treatment being researched are not known
at the beginning of the clinical trial. Since this is
the case, there may be unknown side effects as well
as hoped for benefits.
It is important to note that most treatments, as well
as the condition itself, have potential side effects.
In clinical trials, most side effects from the treatment
are temporary and go away once the treatment is stopped.
Patients will be informed of any known possible side
effects that occur while they are participating in a
trial.
What is informed consent?
Informed consent means that as a patient, you are given
all the available information so that you understand
what is involved in a specific clinical trial. Your
doctor or nurse should explain the treatment to you,
including benefits and risks.
You will be given an informed consent form. Read it
and consider it carefully. Ask the physician or nurse
to explain any parts of the form that are not understandable.
You are free to decide whether or not to take part
in the trial. If you decide to take part in the study,
you will sign the consent form. If you do not want to
participate in the trial, you can say "No." If you choose
not to participate in the trial, your care will not
be affected in any way.
Questions to ask your doctor
If you are thinking about taking part in a clinical
trial, find out as much as possible about the study
before you decide to participate. Here are some questions
you may want to ask your doctor or nurse:
- What is the purpose of the study?
- What have previous research of this drug or treatment
shown?
- What kinds of tests and treatments does the trial
involve? How are these tests given?
- What is likely to happen in my case with, or without,
this new research treatment? (How does this research
study compare with standard treatment options?)
- What phase is this clinical trial?
- How could the clinical trial affect my daily life?
- What side effects can I expect from the clinical
trial? (Remember, side effects may occur from standard
treatments and from the disease itself.)
- How long will the study last?
- Will the clinical trial require extra time on my
part?
- Will my records remain confidential?
- Will the study cost me anything?
- Will I have to be hospitalized? If so, how long
and how often?
- If I agree to withdraw from the clinical trial,
will my care be affected? Will I need to change doctors?
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