 CANCER
RESEARCH
Because Lives Depend On It
IS A CLINICAL
TRIAL RIGHT FOR YOU?
Cancer death rates are falling in the United
States. This good news stems partly from patient
studies – clinical studies or clinical
trials-- that over the years have developed better
treatments for many different cancers, including
breast cancer, colon and rectal cancer, childhood
cancers, Hodgkin’s disease, and testicular
cancer. Today thousands of researchers and patients
throughout the United States are involved in
clinical trials to continue development of better
treatment. Pharmaceutical companies must test
experimental medications before applying to the
U. S. Food and Drug Administration (FDA) for
permission to make them available to the public.
This is done through clinical trials.
What
does “clinical trial” mean?
“Clinical trial” is a research term that refers to medical studies
with people. These studies are one of the steps in the process of developing
new drugs and other means to fight disease. Once a drug has shown promise,
first in laboratory and then in animal studies, it may move on to studies with
people if the FDA allows. Only after a drug proves safe and effective in clinical
trials does the FDA grant approval for marketing the drug.
Clinical trials may study new drugs or other
ways of treating cancer, or they may look at
new combinations of established treatments. Clinical
trials progress in three stages:
- Phase I studies the safety
of an experimental drug or drug regimen.
- Phase II studies determine
the effectiveness of the drug (whether or not
it works to eliminate the cancer.)
- Phase III studies, which
usually involve many patients in different
places, compare the experimental drug in comparison
to the current standard treatment.
Where
do clinical trials take place?
These trials take place in cancer centers, other
major medical centers, community hospitals and
clinics, and veterans’ and military hospitals
all over the country.
Hundreds of clinical trials are carried out
by large networks, called cooperative clinical
groups that are funded by the National Cancer
Institute (NCI). The oncologists (cancer specialists)
who belong to these networks conduct joint studies
simultaneously in many different places and pool
their data.
What
are the benefits of taking part in
a trial?
There may be no direct benefit to individuals
participating in clinical studies. One potential
benefit is the possibility that a new treatment,
diagnostic test or preventive measure will turn
out to be better than a more established procedure,
but this is not guaranteed. In a Phase III clinical
trial patients either receive the most advanced
and accepted treatment for the kind of cancer
they have (known as the “standard”
treatment) or an alternative, investigational
treatment that has shown promise of being at
least as beneficial as the standard treatment.
People who take part in trials are followed
by a study doctor under a very detailed set of
directions or protocol. By investigating clinical
trial options, patients can learn what the best
available standard of care is for their disease
and at the same time come to better understand
their disease. In addition, all clinical trial
patients are carefully monitored during a trial
and followed afterwards.
Many patients have said that they take part
in clinical trials because it is also an opportunity
to contribute to new knowledge that may benefit
others with cancer. Recent studies show that
cancer patients enrolled in clinical trials generally
do as well or better than those who are not enrolled
in trials.
What
are the risks?
Medical studies can carry unknown dangers and
side effects, as well as hoped for benefits.
The risks and benefits of each trial are explained
in a document, called an informed consent form,
which the patients discuss with their doctors
or nurses before agreeing to participate. In
addition, health insurers and managed care providers
do not always cover all the costs for care in
a clinical trial.
What safeguards are there for patients?
Clinical trials are designed with patients’
safety and well-being in mind, both medically
and psychologically. All clinical trials must
be reviewed and approved by the federal government
and by the Institutional Review Board (IRB) of
the hospital or facility administering the trial.
Patients have the right to refuse or terminate
participation in a clinical trial at any time.
How to find out about clinical trials:
- Your doctor is an excellent source of information
about clinical trials.
- Call Gail Probst, RN, Coordinator of Cancer
Services at Huntington Hospital
631-351-2568 and ask for the pamphlet “Is
a Clinical Trial Right for You?
- Call NCI’s Cancer Information Service
(CIS) at 1-800-426-6237 and ask for a customized
search of the PDQ database which provides information
on current trials or visit National Cancer
Institute web site at www.cancer.gov.
- Log on to the World Wide Web at: http://cancertrials.gov/ the National Institute of Health’s website
with information about cancer research studies.
- Log on to www.CancerTrialsHelp.org
Huntington Hospital offers clinical trials
for the following:
- Breast Cancer Treatment Trials
- Prostate Cancer Treatment Trials
- Endometrial Cancer Treatment Trials
- Leukemia and Lymphoma Treatment Trials
- Lung Cancer Treatment Trials
- Head and Neck Cancer Treatment Trials
- Colorectal Cancer Treatment Trials
- Gastric Cancer Treatment Trials
- Transplant Trials for Multiple Myeloma
- Treatment Trials to manage the side effects
of chemotherapy
- Trials comparing methods for smoking cessation
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