Are Clinical Trials for You?
According to the American
Cancer Society, about 1,284,900 new cancer cases will be diagnosed
this year. If you are one of these patients, you should be aware
of the various treatment options available to you – including
clinical trials. At the Joan Karnell Cancer Center at Pennsylvania
Hospital, patients can participate in national clinical trials,
which offer the opportunity to receive new, and potentially more
effective, treatment options.
Surprisingly, 85 percent of cancer patients are not aware that participation
in a clinical trial may be a treatment option,
according to the Coalition of National Cancer Cooperative Groups,
a national network of cancer clinical trial specialists. “My
work includes helping to identify patients who may be eligible to
participate in a clinical trial,” says
Holly Kilpatrick, RN, one of many clinical research
nurses at the Joan Karnell Cancer Center.
“We have more than
60 protocols currently available. The majority of the studies are
government funded while others are funded by pharmaceutical companies.” Many
of these trials are available to us through our membership in the
University of Pennsylvania Cancer Network.
What is a Clinical Trial?
Before the Food and Drug Administration (FDA)
can approve a new drug or treatment protocol, it must undergo three
phases of clinical trials. The first phase begins after extensive
laboratory research, trials on animals and the filing of an Investigational
New Drug application with the FDA. Phase I trials are performed
on small, select groups of patients to determine the correct dosage
and evaluate any possible side effects.
Phase II trials, which generally involve fewer than 100 participants,
are used to determine if the new treatment actually has a positive
effect against cancer. In general, according to the Coalition of National
Cancer Cooperative Groups, if at least 20 percent of patients respond
to the treatment, the new protocol moves on to Phase III.
It is during Phase III that most patients would become involved in
a clinical trial. Here, a large group of participants is needed to
determine how the new drug or protocol compares to the best existing
treatment currently available.
What to Expect
“It’s important that patients realize that by participating in
a clinical trial they are not guinea pigs. Actually, they are offered the best
possible care that is currently available — and perhaps even the best
possible treatments options for the future,” says Kilpatrick. “During
the trial, participants are assigned a specific research nurse who can help
answer questions and provide close, personal follow-up care for their conditions.”
Some patients may also be concerned about receiving placebos but
in those clinical trials where placebos are used (and not all trials
use them), patients still receive standard care. In other words, by
not receiving the drug being tested, the patient is not missing part
of his or her treatment.“ The patient would always get the best
care that’s available,” says Kilpatrick.
What’s involved in committing to a clinical trial? In terms
of cost, most treatment is usually considered standard by medical
insurers and is often covered. In many cases, for those treatments
not covered, the study will provide the funding to have patients treated.
Even patients without insurance may be able to participate in a clinical
trial, assuming they are eligible for the study.
Time is of the essence to everyone and, as a result, some patients
may reject the idea of participation in a clinical study due to time
commitments. In fact, although the length of time a clinical trial
can vary is anywhere from a few months to several years, the amount
of time a patient needs to devote to check-ups and appointments is
generally not that much more than what is required for typical physician
Before committing to a clinical trial, be sure to read the information
provided and make sure you understand it. Write down any questions
you may have and discuss these with your doctor. A clinical trial
is not the only treatment option available to you but it may be one
of the best. Be sure you understand the potential benefits and risks
before you commit.
“It’s also important to realize that you’re not
just gaining access to the best possible care for yourself,” says
Kilpatrick. “You may actually be helping thousands of others
afflicted with cancer. People might one day receive a new drug or
treatment protocol because of your participation in the trial.”
For more information on clinical
trials at the Joan Karnell Cancer
Center, call 1-800-789-PENN (7366).