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Should You Participate?
In order to provide you the very latest in medial care,
the physicians at Gastroenterology Associates of Tidewater
cooperate with major medical centers and pharmaceutical
companies in developing new drugs and techniques in the
care of gastrointestinal disease.
You may be invited to participate in one of our clinical
research trials it is important to understand the benefits
of your participation, your rights and our responsibilities.
Why should I join a clinical research trial?
Provide you access to new drugs, commonly just before
they are marked. This allows you to use the newest, most
cutting-edge medication before they are in the local pharmacies
or before they are release for the medial condition that
you have. May of the trial sin which we participate are
called Phase III trials, which are pre-market studies
used to help identify the exact effectiveness as well
as the often mild and rare side effects of new drugs by
using them in a large number of patients what the appropriate
medical condition. Participation in such trials may provide
you with a better drug earlier than it is available though
the local pharmacy. If you suffer from a disease in which
there are limited successful treatment options, may improve
the future care of others with the same disease.
Participating in a clinical research may also make care
and medications available to you if your insurance company
or your ability to pay for medications and treatment is
poor. Commonly the care that you receive by participating
n a research trial includes laboratories, testing and
careful office evaluation, often at no cost to you or
your insurance.
How much experience
have you had in drug research?
Gastroenterology Associates of Tidewater has been participating
in clinical trials since 1995. We have been involved in
research studies about Hepatitis C, irritable bowel syndrome,
gastroesophageal Reflux Disease (GERD) and bowel preparation
for colonoscopy and many others. All of the drugs and
treatments we have tested have received FDA approval for
use to date
Do you have any special
research personnel?
In addition to our well-trained physicians and nursing
staff who care for your medical needs, gastroenterology
associates of tidewater employs a clinical research coordinator
to assist in the management of our research studies and
patients. Our research coordinator is available for questions
and emergencies during regular office hours. She can answer
questions about study drugs and the design of the study
(also know as the study protocol) our physicians are available
on-call twenty-for ours a day for medical emergencies.
The research coordinator arranges your office visits and
any procedures required by the study, makes sure all appropriate
labs are drawn and sent, enters all data into forms required
by the study and completes an incredible amount of regulatory
paperwork and oversees all your visits while you are on
study. This I your first source of information for questions
and concerns about any study.
What
is a consent form?
If you choose to volunteer for a research study you will
read and sign a consent form. This document will be reviewed
with you thoroughly and a copy of it will be given to
you to keep. included in the consent form is the disclose
to you in “lay-language” all risks and benefits of any
medication or procedures involved in the study, in greater
detail than we usually do for similar non-study related
prescription medications or treatments. It discloses the
study design, or protocol in detail explaining the office
visits, the tests and all known side effects or risks
of medications or treatments. It also explains any benefits
your might expect form participation and your rights as
a subject of research. The consent form for the study
by law must disclose to you any and all information that
is pertinent to your and your participation. All clinical
testing on investigational drugs are reviewed by the U.S.
Government food and drug Administration (FDA) as well
as and institutional review board.( IRB) the IRB’s are
agencies that ensure that any studies or research which
are done on humans are conducted in a fair safe and ethical
manner.
Is it safe to be in a research
study?
Your safety is the main priority during a clinical trial.
It is important to take all our medications as assigned,
keep all your scheduled visits and let the research coordinator
or physician know how you feel and if you have developed
any side effects Participation in a research trial does
not alter your rights to pursue legal action regarding
your medical care, should you deem it necessary.
What is placebo?
If you choose to participate in a research study, it is
a possible that you will be assigned to a placebo drug
rather than the active drug being tested. A placebo is
an inactive of “dummy” pill randomly assigned to some
of the volunteers to compare the results of the drug under
study. The physician, research coordinator and volunteer
do not know who is receiving the placebo, a process which
is known as “blinded”. In some studies all subjects receive
active drug, but different drugs or different dosage.
The chances of receiving a placebo or various drug treatments
must be disclosed to you in the consent form. If you have
medical problems during the study, investigators may call
the director of the study to find out if you are taking
active drug or placebo tablet, a process known as breaking
the blind.
Who determines what drug
or treatment I receive?
The assignment of drug or treatment, as well as placebo
in some studies, is assigned by random chance. Random
chance is like flipping a coin, although the random assignment
now has like been done by a computer I the main research
facility of the pharmaceutical company. We cannot influence
to which group you are assigned. Whether you receive placebo
or the active investigational drug, the level of medical
attention is the same.
Can I stop
my participation in the study?
You may choose to discontinue your participation in a
study at anytime. We ask that you allow us to complete
any testing that is necessary to preserve your health,
but that is voluntary. It may become necessary for your
doctor to remove you from the study. This may be for your
won safety, because you are not following the participation
requirements of the study, or because the study is complete
and the drug has been released.
If you withdraw or are withdrawn from a study, please
return all study medications.
Does
my medical information remain private?
If you participate in a clinical trial, your privacy is
protected, and your medical records remain confidential.
The information provide to the medical centers, pharmaceutical
companies and the FDA will not include any material that
identifies you personally
Why isn’t
this testing done on research animals?
Preliminary tests on these drugs or treatments have often
first been done on animal subjects to prove their safety.
Often studies on the safety of medications during pregnancy
have done solely using animal subjects; as such testing
on human subjects who are pregnant would be extremely
unwise. Many diseases which affect humans have no animal
model – that is, there is no comparable disease in animals
in which w may test new drugs or treatments. Therefore,
studies in human volunteers with the ailment of concern
are necessary to develop new drugs or treatments for use
in man.
Every participant in clinical trial is extremely valuable
and important. Without such volunteers, there would be
no new drugs to fight disease and improve our health.
By participating in a clinical trial, you may help yourself
and others like you to live longer healthier lives, no
and long into the future.
If you have any further questions regarding participation
in a research trial please contact our clinical
research coordinator at 757-547-0798 extension 1109.
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