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Earlier this year I
had my third colonoscopy in three years. A colonoscopy is
a procedure that detects and prevents colon cancer. In all
three procedures my physician had removed pre-cancerous polyps.
If these polyps had gone undetected they could have developed
into cancerous tumors. Following this last colonoscopy I was
asked to join a three-year research study intended to investigate
if a certain experimental drug can decrease or prevent the
recurrence of polyps.
Today cancer of the colon,
like AIDS, is one of the worst killers in the United States.
This is mainly because of stigmas attached to disease and
discomfort in dealing with treatment. I decided to join this
study because if this experimental drug is successful it may
reduce the risk of colon cancer in individuals like myself.
People take part in clinical
trials for a number of reasons. You may want to help in the
development of medical therapies and vaccines that may help
treat or even cure life-threatening and chronic diseases.
You may suffer from a disease for which good treatments do
not presently exist, and decide to join a study hoping to
obtain improved medical care. Or you may not have health insurance,
and clinical trials provide study related medical care.
A clinical trial is a study
that is carefully monitored by a physician or a research professional.
They are usually conducted in four phases (I, II, III, IV).
Each phase requires a larger number of participants. They
require people like you and me to volunteer to receive investigational
treatments. All clinical trials are reviewed by the U.S. government’s
Food and Drug Administration (FDA) and by Institutional Review
Boards (IRBs). The IRB ensures that your rights and privacy
are protected, that you aren’t exposed to any unnecessary
risks, and that you have signed a consent form prior to entering
a trial.
Once accepted into a study
group you will receive a physical examination. Your physician
or research professional will review your medical history.
A detailed description of your specific clinical trial, what’s
expected, duration and expected outcomes will be outlined.
You will then be placed into a study group.
In order to make your experience
in a clinical trial a safe one, it is important that medication
is taken as prescribed, that you keep all scheduled appointments,
and that you keep a log of how you are feeling between appointments.
The information you provide in regards to any symptoms or
side effects you may experience is valuable.
There are a number of valuable
resources available if you are considering entering an AIDS
clinical trial. The AIDS Clinical Trial Information Service
is confidential, maintains a trained staff and provides a
list of new drugs being tested, where studies are being conducted
and who is running the studies (available Monday-Friday 9
am to 7 pm EST, 1-800-TRIALS-A [874-2572]). In addition, the
American Foundation for AIDS Research (amfAR) provides information
on both basic-biomedical and clinical AIDS research (1-212-806-1600,
txdir@amfar.org and www.amfar.org).
For whatever reasons that
you might choose for taking part in a clinical trial, it’s
ultimately important that you make an informed choice and
have all of your questions about the trial and study drug
answered. And remember you have the right to leave a study
at any time and for any reason.
Charles E. Clifton
Editor
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