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The doctors at AAIR Research Center have been conducting
clinical trials together with pharmaceutical companies for
over 35 years.
What is a Clinical Trial?
A clinical trial is a controlled scientific study done with
an investigational medication to test the medication's effectiveness
and safety on human beings. Many years are spent testing medications
in the laboratory and in animal research to determine the
medication's safety and usefulness before clinical trials
are conducted to determine the medication's effect on humans.
The Food and Drug Administration (FDA) requires clinical trials
on all medication before they will approve a medication for
public use. Clinical trials help us find better and new ways
to treat illness and disease.
Are There Different Types of Clinical Trials?
Clinical trials are done in four phases. Phase I is the first
phase in testing. These studies use healthy volunteers, are
short-term and establish the safety and tolerance of the medication
in humans. Phase II studies are short to medium length and
use volunteers with an appropriate disease for the medication
being studied in order to define medication dosages and establish
effectiveness of the medication. Phase III studies are the
last studies done before the medication is submitted for approval.
Phase III studies vary in length from several months to several
years and use many volunteers with the appropriate disease
for the medication being studied. These studies try to determine
the medication's safety and effectiveness with selected dose
in a large sample of volunteers and determine guidelines as
to how the medication can be used. Phase III studies usually
include a placebo (sugar pill) which means that some patients
are not on active medication. Phase IV studies are conducted
after the medication has been approved . Phase IV studies
continue to monitor the safety of the medication in large
groups of volunteers. AAIR Research conducts Phase II, III,
IV studies, with the majority being Phase III studies.
What Clinical Trials is AAIR Involved With?
AAIR Research has and continues to perform clinical trials
in asthma, allergies, arthritis, sinusitis, and auto immune
diseases including fibromyalgia, Raynaud's Phenomenon, lupus
and Sjogren's Syndrome in adults and children. We are always
looking for volunteers to participate in our clinical trials.
Why Participate in a Clinical Trial ?
People join in a study to try to help themselves and to help
others. The medication being tested may improve health and
quality of life in those being studied. The end result of
the study may be a discovery that could help people now and
in future generations all across the country and around the
world.
What Should a Study Participant Expect?
Clinical trials consist of office visits similar to visits
you would make to your own doctor and may include EKGs, x-rays,
pulmonary function tests, physical examinations and labwork.
Each trial consists of procedures specific for that trial.
All study related procedures and medication are provided free
of charge. Each trial has its own specific requirements that
must be met to be in the study. Trial participants are treated
professionally and with respect. Participants receive our
personal attention. Participants may receive a payment to
cover travel expenses and for their time spent in the study.
You will receive a consent form to read and sign. The informed
consent form provides you with information about the study.
It is a document that describes the study, including the schedule
of visits, what is expected of you, procedures that will be
done, the name and phone number of a person you can contact
with questions or problems, the amount of monetary compensation,
and a discussion of any potential risks and benefits. You
are encouraged to show the consent form to your primary care
physician. All your questions should be answered before you
sign the informed consent and no study procedures will be
done before the informed consent is signed.
Your decision to take part in a research study is voluntary
at all times. If you decide not to participate in the study,
or if you decide to withdraw from the study before it is complete
for any reason, there will be no penalty to you. If you are
a patient of our medical practice, your decision not to participate
in a research study or to withdraw from a study will not affect
your medical care from our practice in any way.
AAIR Research has 6 doctors, a nurse practitioner and 6 nurse/medical
assistants (clinical research coordinators) conducting clinical
trials in a friendly, informal office.
How Can I Find Out More Information?
Please call us at 442-1980 to find out more information about
becoming a study volunteer.
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