|
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.
▲ BACK
TO TOP OF PAGE ▲
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 of 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.
▲ BACK
TO TOP OF PAGE ▲
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.
▲ BACK
TO TOP OF PAGE ▲
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.
▲ BACK
TO TOP OF PAGE ▲
For more
information about clinical trials, please visit:
http://www.clinicaltrials.gov |
