Frequently Asked Questions About Clinical Trials
What
is a Clinical Trial?
Why participate in a clinical trial?
What
happens during a clinical trial?
What
is a protocol?
What
is informed consent?
What
are the benefits and risks of participating in a clinical
trial?
How is
the safety of your child being protected?
What
you should consider before allowing your child to
participate in a trial?
Can my
child leave a clinical trial after it has started?
Where
do the ideas for trials come from?
Who
sponsors clinical trials?
Summary
What is it all about?
What is a Clinical Trial?
A
clinical trial (also clinical research) is a research study
in human volunteers to answer specific health questions.
Before new drugs and other therapies can be marketed, their
usefulness, safety and effectiveness must be
well-understood. Carefully conducted clinical trials are the
fastest and safest way to find treatments that work in
children and ways to improve children’s health.
Why participate in a clinical trial?
Clinical
trials offer access to new research treatments before they
are widely available. Children and families who participate
in clinical trials help others by contributing to medical
research and medical knowledge.
What happens during a clinical trial?
The clinical trial team includes doctors, nurses, and
research coordinators, as well as other health care
professionals. They check the health of your child at the
beginning of the trial, give specific instructions for
participating in the trial, and monitor your child carefully
during the trial,
Some clinical trials involve more tests and doctor visits
than your child would normally have for an illness or
condition. For all types of trials, you and your child work
with a research team. Clinical trial participation is most
successful when the protocol is carefully followed and there
is frequent contact with the research staff.
What is a protocol?
A protocol is a study plan that is carefully designed to
safeguard the health of your child as well as answer
specific research questions. A protocol describes what types
of people may participate in the trial; the schedule of
tests, procedures, medications, and dosages and the length
of the study. While in a clinical trial, your child will be
seen regularly by the research staff to monitor your child’s
health and to determine the safety and effectiveness of
treatment.
What is informed consent?
Informed consent is a process where you and your child
receive a thorough explanation about the research study and
have the chance to ask questions and discuss participation
with your doctor or nurse. As part of this discussion, you
will be asked to sign a consent form indicating that you
understand the study and are willing to participate. The
risks, potential benefits and inconveniences of any tests or
procedures are explained in the informed consent document.
The document describes your rights as a participant and
actions to protect your confidentiality. You will be
encouraged to ask questions until you feel comfortable that
you understand the study and what is involved should you and
your child decide to participate. If your child is under the
age of 18, only the child’s parent or legal guardian can
sign a consent form. In some cases, children over the age of
seven years will be asked to read and sign an Assent form,
indicating that he or she agrees to participate.
The informed consent process continues throughout the study
and you will be encouraged to ask questions at any time. You
and your child may withdraw from the trial at any time
without any type of penalty.
What are the benefits and risks of participating in a
clinical trial?
Benefits
Since the drug or other therapy is still being tested, many
clinical trials may not offer direct benefit for your child.
However, clinical trials that are well-designed and
well-executed help you and your child gain access to new
research treatments before they are widely available and
provide opportunities to help others in the future by
contributing to medical knowledge.
Risks
There may be risks to your child by being in a clinical
trial.
- There may be unpleasant, serious or even life-threatening
side effects to experimental treatment.
- The experimental treatment may not be effective for your
child.
- The protocol may take more time and attention than would a
non-protocol treatment, including trips to the study site,
more treatments or complex medication requirements.
How is the safety of your child being protected?
The ethical and legal codes that govern medical practice
also apply to clinical trials. In addition, most clinical
research is federally regulated with built in safeguards to
protect your child. Before any study can be offered at CCMC,
it must be approved by a special committee responsible to
protect human subjects in research, known as the Connecticut
Children’s Medical Center Institutional Review Board (IRB).
The IRB is an independent committee of physicians, community
advocates and others who assure that a clinical trial is
ethical and the rights of your child are protected. The IRB
must review, approve and monitor all research at CCMC. As a
clinical trial progresses, researchers report the results of
the trial at scientific meetings, to medical journals, and
to various government agencies.
What you should consider before allowing your child to
participate in a trial?
You and your child should know as much as possible about the
clinical trial and feel comfortable asking the members of
the health care team questions about it, the care expected
while in a trial, and the cost of the trial. The following
questions might be helpful for you to discuss with the
health care team. Some of the answers to these questions are
found in the informed consent document.
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment
being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are
involved?
- How do the possible risks, side effects, and benefits in
the study compare with my child’s current treatment?
- How might this trial affect my child’s daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this
study?
- How will I know that the experimental treatment is
working? Will results of the trials be provided to me?
- Who will be in charge of my child’s care?
Can my child leave a clinical trial after it has started?
Yes. You and your child can leave a clinical trial, at any
time. When withdrawing from the trial, you should let the
research team know about it, and the reasons for leaving the
trial.
Where do the ideas for trials come from?
Ideas for clinical trials can come from laboratory research
or from clinical practice. After researchers test new
therapies or procedures in the laboratory and in animal
studies, the experimental treatments with the most promising
laboratory results are moved into clinical trials. During a
trial, more and more information is gained about an
experimental treatment, its risks and how well it may or may
not work.
Who sponsors clinical trials?
Clinical trials 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). Trials can take place in a variety of
locations, such as hospitals, universities, doctors'
offices, or community clinics.
So in summary, as a Research Subject you and your child have
a right to information about:
- Why the study is being done.
- What will happen during the study
- How participating would change your child’s medical care
- The discomforts and risks of the things that will be done
to your child in the study
- Possible benefits of taking part in the study
- Other treatments that are available if your child chooses
not to be in the study
- Medical treatment if problems occur during the study
You and your child also have the right to:
- Decide NOT to take part in the study
- Not be pressured to take part in the study
- Stop being in the study at any time
- Ask questions before, during, and after the study
- Receive information throughout the study
What is it all about?
Clinical research allows us to be at the cutting edge of the
latest clinical treatments and practices. Sometimes being
asked to participate in a clinical research study can be
confusing. We hope this information will help you understand
more about research and allow you to decide if you would
want your child to be in a research study if asked to
participate.
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