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CLINICAL TRIALS
AT UM/SYLVESTER
W
HAT IS THE
PURPOSE OF
THIS BROCHURE?
We created this brochure for people
who may be interested in learning
about or participating in clinical
trials, also called clinical or research
studies. New clinical trials are
under development every day at
UM/Sylvester -- to find more
effective treatments for cancer and
other serious illnesses. Clinical trials
allow patients to participate in the
newest treatments with potentially
life-saving therapies.
To learn more about
UM/Sylvester’s Clinical Trials
Matching Service for cancer
patients, visit www.sylvester.org
or call 1-866-574-5124.
WHAT IS A CLINICAL TRIAL?
A clinical trial is a type of research study that tests
how well new medical approaches work in people.
These studies test new methods of screening,
prevention, diagnosis, or treatment of a disease.
Clinical trials are conducted in all areas of medicine.
UM/Sylvester conducts a wide range of clinical trials
and those focused on cancer care help physicians
and scientists answer specific questions about new
therapies or new ways of using known therapies –
allowing patients access to the newest treatments
under development.
WHY ARE CLINICAL TRIALS IMPORTANT?
Clinical trials contribute to knowledge and progress
in the fight against cancer and other serious illnesses.
Every trial weighs the risks versus the benefits for the
participants, with the goal to minimize risk and
maximize benefits.
If a new treatment proves to be safe and effective
in a clinical trial, it may become a new standard
of treatment that can help many patients.
Many of today’s most effective standard treatments
are based on the results of previous clinical trials.
Patients who participate in clinical trials will receive
either the new treatment being tested or the current
standard of care for their illness. New therapies
may carry unknown risks. But if a new remedy
proves effective or more effective than the
current standard of care, clinical trial participants
are the first to benefit.
WHAT HAPPENS IN A CLINICAL TRIAL?
In a clinical trial, patients receive new therapies,
medications, or sometimes even complementary or
alternative therapies while doctors study the effects
of these treatments. Although clinical trials may
carry certain risks to the participants, steps are
taken in every study to monitor for possible side
effects and minimize risk.
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Patients who participate in a clinical trial may receive
care at UM/Sylvester, a hospital, a clinic, and/or a
doctor’s office. Their treatment teams may include
physicians, nurses, social workers, and other health
professionals, all of whom follow the patient’s
progress closely. Patients follow treatment plans
for a specified length of time as prescribed by
their physicians, and also may have other
responsibilities such as keeping a log or filling out
forms about their health.
Patients also may be asked to participate in
non-therapeutic trials where there are no anticipated
clinical benefits and only carry minimal risks to
patients, e.g., collection of data via blood tests.
HOW IS THE RESEARCH CARRIED OUT?
HOW ARE PATIENTS PROTECTED?
In clinical trials, patient safety and the research
outcomes are of the utmost importance. In the United
States, the Food and Drug Administration (FDA)
monitors clinical trials to ensure safe and effective
drugs are available to the public. In order to protect
patients and to ensure accurate results, clinical trials
must adhere to strict scientific and ethical guidelines.
These include:
1. A Plan That Explains How The Trial Will Work
The clinical trial investigator (often referred to as
principal investigator or PI), usually a physician,
prepares an action plan (or “protocol”) for the clinical
trial. This plan describes the purpose of the clinical
trial as well as the procedure. It also outlines the
number of participants who will take part in the
trial, the type and frequency of medical tests each
patient will receive, and the treatment plan.
Each physician involved in the clinical trial must follow
the same protocol.
For patient well-being, each protocol must be
approved by the clinical trial’s “sponsor organization”
(such as UM/Sylvester) and UM/Sylvester’s Institutional
Review Board (IRB) at each clinical trial site.
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The IRB, which includes members of the community,
clergy, and health professionals, reviews the protocol
to assess the potential benefits and risks of
participating in the trial.
2. Eligibility Requirements For Study Participants
The protocol for each clinical trial names specific
characteristics – or eligibility criteria – that all
patients must share. These may include age, gender,
and the type of illness, as well as prior treatment and
medical history.
Eligibility criteria are important in medical research
for several reasons. During the clinical trial screening
process, criteria help ensure patients with appropriate
conditions enroll, while patients with medical
disorders that may increase risk are excluded from
testing. After a clinical trial, the criteria can help
dictate which patients will benefit from the new
medication. For instance, a new treatment may be
effective against one type of cancer or illness but
not another, or it may be more effective for men
than women.
3. A Controlled Process With Different Phases
To Answer Different Scientific Questions
Most clinical research that involves the testing of a
new drug progresses in an orderly series of steps,
called phases. This allows physicians and scientists
to ask and answer questions in a way that results in
reliable information about the drug and protects the
patients. Clinical trials are usually classified into one of
four phases:
• Phase I trials are the first step in testing a new
treatment in humans. In these clinical trials,
scientists investigate if and how the medication can
be provided including proper dosage and defined
side effects. A Phase I trial usually enrolls only a
small number of healthy volunteers or patients with
a specified illness (such as cancer) with limited
treatment options. Phase I trials also look for
the best way to administer a new medication
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(by mouth, injected into the blood or muscle)
as well as how frequently to administer it.
• Phase II trials begin to evaluate how well new
medications work in a particular patient
population, and further define side effects at
that dose. (For instance, whether a drug shrinks
a tumor or improves blood test results.)
Generally, only a small number of patients
participate in Phase II trials, which usually
focus on a particular type of cancer.
• Phase III trials test a new drug, a new
combination of drugs, or a new surgical
procedure in comparison to the current standard
of care. A participant usually will be assigned to
the standard group or the new group at random
(called randomization). Phase III trials often
enroll large numbers of patients and may be
conducted at many doctors’ offices, clinics,
and cancer centers nationwide.
• Phase IV trials are conducted once a medication
has been approved by the FDA to find new
indications or newer ways of using existing
medications. These studies continue to evaluate
the medication to learn more about its long-term
benefits and side effects.
SHOULD YOU TAKE PART IN A CLINICAL TRIAL?
While clinical trials have helped many people beat
cancer and other illnesses, and helped establish
preventive, diagnostic, and treatment therapies that
have become standard clinical practice, they may
not be appropriate for everyone. This is a question
only you and your physician can answer. Learning
you have a serious illness and deciding what actions
to take can be overwhelming. Participating in a
clinical trial may be a good choice for some people,
but anyone who considers participating in a study
should be aware of potential risks and benefits.
• Possible Benefits – Clinical trials offer high-quality
care, and may provide access to new treatments
that are eventually proven effective as part of a
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study prior to FDA approval. If you participate in a
clinical trial and do not receive the new treatment
being tested, you will receive the current standard of
care as well as careful monitoring of your condition
and any possible side effects to the standard
treatment.
Some studies involve incentives such as payment
or a gift for participation.
• Possible Risks – New treatments under investigation
are not always better than, or even as good as, the
current standard of care. There is always a potential
for unexpected side effects, which may be worse
than side effects from the current standard of care.
Even if a new approach has benefits, it may not work
for everyone. In addition, studies usually involve
some degree of risk, but if study-related injury
occurs, treatment will be available in most cases.
Also, health insurance and managed care providers
may not cover all the patient care costs of a clinical
trial. To be sure, you should always inquire in
advance to determine what costs your health care
provider will pay, and talk to the physician, nurse,
or social worker involved with your clinical trial.
YOUR RIGHTS AND YOUR PROTECTIONS
One of your most important rights as a patient is the
right to informed consent. Informed consent means
you must be given all of the facts about a clinical trial
before you agree to participate. This includes details
about any treatments and tests you may receive and
any known possible benefits or risks involved.
Your doctor or nurse will give you an informed consent
form that includes all of the facts
concerning your clinical trial. If you decide to take part
in the clinical trial, you will be asked to sign
this consent form.
Signing a consent form does not mean you must
complete the clinical trial. You may elect to stop
participating in the clinical trial at any time. If you
decide to leave a clinical trial, you can then discuss
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other treatments and care options with your doctor.
At all times, your medical records and associated
information remain confidential to the extent
permitted by law.
If you have any questions or concerns about your
participation or care in a UM/Sylvester clinical trial,
please contact the University of Miami’s Human
Subjects Research Office (HSRO) at 305-243-3195.
CLINICAL TRIALS MATCHING SERVICE
On November 1, 2004, leaders in Florida’s cancer
community launched the Florida Cancer Clinical
Trials Cooperative, Inc. (FCCTC), in an effort to
provide expanded treatment options for Floridians
who are fighting cancer. The FCCTC Information and
Matching Service, powered by EmergingMed,
is an interactive, web-based system that enables
cancer patients and others to access clinical trials
available throughout Florida.
In May 2005 – as an outgrowth of its participation in
the FCCTC – UM/Sylvester launched its own Clinical
Trials Matching Service, which is designed to provide
a fast, simple, and confidential way to access
information about clinical trials in South Florida,
throughout the state, and the nation. To learn more
about cancer trials at UM/Sylvester, visit our website
at www.sylvester.org or call 1-866-574-5124.
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To see a UM/Sylvester cancer specialist
for an initial visit, second opinion, or
clinical trial screening, call 305-243-1000,
1-800-545-2292, or visit UM/Sylvester’s
website at www.sylvester.org
and click on Clinical Trials.
To contact UM/Sylvester’s Clinical Trials
Matching Service directly,
call 1-866-574-5124.
UM/Sylvester Comprehensive Cancer Center
1475 N.W. 12th Avenue
Miami, Florida 33136
305-243-1000
1-800-545-2292
UM/Sylvester at Deerfield Beach
1192 East Newport Center Drive
Suite 100
Deerfield Beach, Florida 33442
1-800-545-2292
www.sylvester.org
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