Patients key to advancing cancer treatment through clinical research, con't.
Who should consider
a clinical trial?
The best time to consider a clinical trial is
when you are newly diagnosed or when
there's a change in your cancer -- for example,
if it has spread or recurred. Each
trial has strict eligibility criteria. Talk with
your doctor to find out whether any studies
are available to you or call the Cancer AnswerLine™ at 800-865-1125.
Q: What about patient safety?
All clinical trials are reviewed -- from start to finish -- by the Institutional Review
Board. That's a group of doctors, healthcare professionals and community members who review every clinical trial to ensure that
it is safe for patients, well-designed, legal and ethical. The treating physician will offer patients the option to participate in a study
if an early assessment shows that he or she is likely to be eligible. The patient is then provided with an informed-consent form, which
is a document that explains everything that can possibly happen during the trial. This is discussed very carefully with the patient
and he or she is advised to read it carefully, take it home, think about it some more and discuss it with family. Patients do not have
to make a decision on the spot about participating in a research study. Patients who participate in studies are carefully monitored by
their physicians. If any issues arise, patients are encouraged to call their health-care team -- day or night. Additional care as part
of the study is based on how well patients are tolerating the intervention. If a study drug proved to be too toxic, it would be
halted or changed to ensure patient safety. We, as doctors, take our responsibility for patients' safety very seriously.
Q: Can a patient quit a study?
Absolutely. If a patient at some point
feels uncomfortable about continuing for any reason, they have the right to withdraw with no questions asked. Furthermore, even
if a patient wants to stay in a study, if his or her doctor determines that it isn't safe, the doctor can remove them from the trial.
Q: Are placebos, or sugar pills,
used in cancer clinical trials?
First, let me debunk a myth: We never deny patients treatment for their cancer. All
of our clinical trials are grounded in science that leads us to believe that the experimental therapies we are testing in clinical trials may
work. In the vast majority of trials, placebos would not be used alone in a situation where we already have a treatment that is proven to help a patient. A placebo may
be used if doctors are evaluating whether adding a new drug to a standard treatment would work better that the standard treatment
alone. Sometimes patients who receive placebos may be offered the study drug later in the trial if it appears that the drug is helpful. In any case,
doctors must inform patients about available treatments and will not delay treatment. Ultimately, it's up to the patient to decide whether
participating in a research study is right for her or him.
Q: Will health insurance cover
the costs of clinical trials?
The costs of procedures that are part
of standard cancer care are generally covered by insurance. Procedures that are for research only -- for example, a blood test to
assess the effects of an experimental drug -- may not be covered. Often, researchers can find funds to cover these costs for patients.
The informed-consent form will fully outline what types of costs patients may have to bear if they participate.
Q: Will a patient enrolled in a clinical trial get better care than someone who isn't
Although there are not specific studies
for every situation, we all agree as physicians that in diseases where there are no effective treatments or cures, clinical trials
offer hope. In my opinion -- and many experts share my assessment -- patients will get better care on a clinical trial.
Q: How do you balance hope while providing patients with realistic expectations?
Clinical trials are well thought out.
There's always a fair amount of science behind a clinical trial that suggests that the question being studied is legitimate and
that there is a reasonable chance that something valuable will come out of it. We don't do anything without a burden of
information that gives us confidence. Obviously, there is no guarantee of benefit. But it's like playing the lottery: You don't
win if you don't buy a ticket.
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