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WHAT IS A CLINICAL TRIAL?
Clinical
trials are carefully regulated studies sponsored by
pharmaceutical and bio-technological companies and are
made possible by people like you who volunteer to
receive investigational treatments. Qualified
physicians and other research professionals supervise
clinical trials that are approved by the U.S.
government's FDA as well as Institutional Review
Boards. Clinical testing of a new drug is a
step-by-step process that ensures you receive careful
medical attention.
In a
clinical drug trial the volunteer is randomly (like
the flip of a coin) assigned to receive one of three
kinds of medication: an investigational medication
(the study drug), a medication already available on
the market, or a placebo. A placebo is a harmless,
inactive medicine used for comparison with the study
medication. Throughout the study the volunteer returns
for regular check-ups to make sure that the treatment
is safe and effective.
WHY SHOULD I JOIN?
By
volunteering in a clinical trial, you help in the
development of new medical therapies that may offer
better treatment, or even cures, for life-threatening
and chronic diseases. People participate in clinical
trials for various reasons: to help in the advancement
od science, to get medical care or in hopes of trying
the latest treatment for a particular disease or
condition.
It's
important that you make an informed choice about
volunteering for a clinical trial. Before signing an
informed consent form, you must read it, understand
it, ask questions about it and most importantly, feel
comfortable with it. You always have the right to
withdraw from the trial at any time, for any reason.
TRIAL PROCEDURES
After
enrolling, you will receive a physical examination, a
review of your medical history and a detailed
description of your specific clinical trial and what's
expected of you. You should feel free to discuss your
medical treatment with your regular provider at any
time.
You will
need to keep scheduled visits, follow medication times
and doses, and honestly communicate with your
physician and research professional. Your medical
records are confidential, and your privacy is
protected.
POST TRIAL FOLLOW UP
After the
study is done, you will return to your usual medical
care. Occasionally, a pharmaceutical company might
continue to provide the study medication to those who
have a serious illness and are responding well.
Sometimes volunteers will stop receiving the
investigational treatment and may have to wait for the
drug to become available to the public.
All
information from the clinical trial is collected and
analyzed. This information determines whether a drug
is safe and effective. FDA medical advisors and
specialists review the information before approving
any new drug. Even after a drug is approved,
pharmaceutical companies will continue to conduct
studies that compare the new drug to other drugs on
the market. Other studies might be conducted to
determine if a treatment can be given to children or
special populations, or to assess a drug's long-term
impact on the quality of a person's life.
To see if you qualify as a research
study volunteer, please fill the
online
study eligibility form.
A member of our staff will contact you soon with more details.
You can also call us at
954.374.1150.
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