What is a clinical trial?
NEXTTOP
A clinical trial is a research study that evaluates
a new treatment. Clinical trials rely on the
participation of patients who volunteer to try new or
modified treatments. Clinical trials help scientists
determine the safety and effectiveness of new
therapies.
All therapies that Huntsman Cancer Institute
investigates through clinical trials have been
thoroughly researched in the laboratory. Laboratory
results have given researchers reason to believe these
treatments could prove to be more effective than
current cancer therapies or will provide additional
treatment options for cancer patients and the NEXT step
is to study them in a clinical, rather than laboratory,
setting.
Why would I be interested in clinical trials?
PREVIOUSNEXTTOP
Usually patients participate in clinical trials
because they hope to benefit themselves and because they
want to contribute to a research effort that helps other
cancer patients.
Researchers conducting clinical trials of a new cancer
therapy believe that it could be more effective than the
current standard treatment, so patients in a clinical
trial may receive the benefit of the new treatment before
it would otherwise be available. Whether the outcome is
beneficial or disappointing, patients involved in
clinical trials are helping to find new and better
treatments for cancer.
How do patients know whether they qualify for a clinical trial at Huntsman Cancer Institute?
PREVIOUSNEXTTOP
Together, the patient, the patient's physician, and
those who administer Huntsman Cancer Institute's clinical
trials decide whether a patient is eligible to
participate in a specific study. Each clinical trial
looks for patients with a specific type and stage of
cancer who are in a relatively good state of health. All
patients treated in a particular clinical trial must be
in a similar physical condition in order to accurately
compare the results of experimental therapies. In
general, you must:
- Have your cancer diagnosed
and then "staged," which means evaluated for how far it
has spread.
- Have your general health status reviewed by a physician.
- Have all of your treatment-related and
clinical trial questions answered to your satisfaction.
- Give your
informed consent, which means that you understand the
possible risks and benefits of participating in a
clinical trial.
What are the risks of participating in a clinical trial?
PREVIOUSNEXTTOP
Clinical trials of new treatments may cause side
effects. Some side effects are known and expected, but
others may not be known ahead of time. Though researchers
make every effort to discover and explain to patients
what side effects may occur from trial cancer treatments,
serious side effects are a possible outcome from
participation in clinical trials.
A patient's well-being is paramount in a clinical
trial. If you are involved in a clinical trial, you will
be closely monitored to see how you are responding to
treatment and to determine your overall well-being. If
the experimental treatment becomes clearly detrimental to
you, it will be discontinued. In addition, you may
withdraw from the study at any time if you change your
mind about participating in it.
What kinds of clinical trials are there?
PREVIOUSNEXTTOP
There are three "phases" of clinical trials:
Phase I clinical trials are first-time tests of
drugs or treatments on human patients. Though the drug or
treatment has not yet been tested on people, researchers
have reason to believe that it will be beneficial. At
this stage, researchers do not know the drug's
effectiveness, the best dose to administer, or what side
effects may occur. A suggested starting dose for humans
is found through laboratory experimentation. All patients
involved in Phase I clinical trials receive a form of
treatment for their cancer; none are administered
placebos (medically inactive agents sometimes used in
medical research for comparison purposes).
Phase II clinical trials begin once an
appropriate dosage of the drug is defined through Phase I
trials. In this stage of testing, researchers will
determine the drug's effectiveness in treating a specific
kind and stage of cancer. As in Phase I clinical trials,
all patients involved in Phase II clinical trials receive
active treatment; none are administered placebos.
Phase III clinical trials test agents that have
proven to be effective in the first two stages of
testing. Phase III clinical trials put the new
(investigational) therapy in perspective. For example, a
phase III trial may compare the current standard therapy
against the new investigational therapy. Or, it may
compare patients given the investigational therapy and
standard therapy with those who are administered only the
standard therapy. Patients participating in Phase III
trials are randomly assigned to one of the treatments in
the study. This means a patient is selected by chance to
be in one treatment group or another. This randomization
is essential to allow investigators to determine which
therapy is truly more effective. While Phase I and Phase
II trials may involve a few dozen patients, Phase III
trials can include hundreds of patients.
What does it cost to be in a clinical trial?
PREVIOUSTOP
Some of the costs associated with the clinical trial
may be paid by the study sponsor. However, because nearly all clinical trials
include administering some standard treatment to the
patient, some costs are billed to the insurance company
and/or the patient (any "standard" treatment charges can
be billed to the insurance provider). Before you enroll
in a clinical trial, you should understand what costs
will be paid by the study sponsor, what
costs will be charged to your insurance company, and
which costs may be billed to you.
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