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| QUESTIONS ABOUT CLINICAL
TRIALS |
WHAT
ARE CLINICAL TRIALS?
WHY
ARE CLINCAL TRIALS IMPORTANT?
WHAT
HAPPENS IN A CLINICAL TRIAL?
SHOULD
I TAKE PART IN A CLINICAL TRIAL?
WHAT
ARE MY RIGHTS AND PROTECTIONS?
QUESTIONS
I SHOULD ASK
WHAT ARE CLINICAL TRIALS?
Clinical trials, also called cancer treatment or research studies
test new treatments in people with cancer. Many times, clinical
trials are testing new drugs or new combinations of drugs, new
types of surgery or radiation therapy, and even methods of gene
therapy. The goal of the research is to find better ways to
treat cancer, and help cancer patients.
A clinical trial is often the end of a long research process
that begins in the laboratory, where doctors and scientists
test new ideas. If the idea seems promising, they will then
test it on animals with cancer to see how it affects cancer
in a living being, and whether it has any harmful side effects.
Then the ideas are tested in humans with cancer to find out
whether promising treatments are safe and effective.
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WHY ARE CLINCAL TRIALS IMPORTANT?
Clinical trials contribute to knowledge and progress against
cancer. If a new treatment proves effective in a study, it may
become a treatment that will help many people with cancer. Many
of today's most effective treatments are based on previous study
results.
Clinical trials may also answer important scientific questions
and suggest future research directions. Because of the progress
made through clinical trials, many people treated for cancer
are now living longer.
Patients who take part in a clinical trial may be helped personally
by the treatment they receive. They get the best treatment available
from cancer experts, and they will receive either a new treatment,
or the best available treatment for their cancer. Patients enrolled
in a clinical research study may be among the first to benefit
from the new treatment.
Clinical trials have sometimes been seen as a last resort for
people with cancer who had no other treatment options. Today,
many patients with common cancers often choose to receive their
first treatment in a clinical trial.
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WHAT HAPPENS IN A CLINICAL TRIAL?
In a clinical trial, patients receive treatment, and doctors,
nurses, and research associates carry out the research on how
the treatment affects the patients. While clinical trials have
risks to the people who take part, each study also takes steps
to protect the patient.
When you take part in a clinical trial, you will receive your
treatment at the hospital or your physician office. Your progress
is followed closely. You may have more tests or more frequent
doctor visits than you would if you were not taking part in
a study. You will follow your physician's instructions and treatment
plan. You may be asked to complete questionnaires or to keep
a journal about your health status. Some studies will follow
patients for their entire lifetime.
In clinical trials, both research concerns and the patient's
well being are important. To help protect patients and produce
sound results, research with people is carried out according
to strict scientific and ethical principles. These are listed
below:
A. Each clinical trial has an action plan, or protocol that
explains what is to be done and how it is to be done and why.
All doctors who are asking patients to take part in the study
follow this plan. The protocol must be strictly followed. For
patient safety, before a protocol may be used, the study must
be approved by the organization that sponsors the study. In
the case of the studies used here at MVCC, the National Cancer
Institute approves all studies. Locally, the studies must then
be approved by the Institutional Review Board (IRB) at each
hospital or clinic. This board assures that the research will
not expose patients to extreme or unethical risks.
B. Each study enrolls cancer patients who are alike in certain
ways, or who meet the exact same criteria for enrollment. Each
study describes certain characteristics that all patients in
the study must have. These are referred to as eligibility criteria.
Criteria may differ from one study to the next. Using eligibility
criteria helps to produce reliable results. It also helps doctors
to know which patient groups will benefit.
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SHOULD I TAKE PART IN A CLINICAL TRIAL?
This is a question only you, those close to you, and your health
care professionals can answer together. Learning you have cancer
and deciding what to do about it is often overwhelming. While
it may be a good choice for some people, there are benefits
and drawbacks. You will want to discuss them with your doctor
and the people close to you.
POSSIBLE BENEFITS:
*Clinical trials offer high-quality cancer care. If you are
in a clinical trial study and do not receive the new treatment
being tested, you will receive the best standard treatment.
This may be as good as, or better than, the new approach
*If a new treatment approach is proven to work and you are taking
it, you may be among the first to benefit
*By looking at the pros and cons of clinical trials and your
other treatment choices, you are taking an active role in a
decision that affects your life.
*You have the chance to help others and improve cancer treatment
POSSIBLE DRAWBACKS:
*New treatments under study are not always better than, or even
as good as, standard care. They may have side effects that doctors
do not expect or that are worse than those of standard treatment
*Even if a new treatment has benefits, it may not work for you.
Even standard treatments, proven effective for many people,
do not help everyone.
*If you receive standard treatment instead of the new treatment
being tested, it may not be as effective as the new approach
*Health insurance and managed care providers may not cover patient
care costs. This will need to be looked at in advance of entering
the study.
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WHAT ARE MY RIGHTS AND PROTECTIONS?
Before and during participation in a cancer treatment study,
you have a number of rights, and knowing them will ultimately
protect you.
*Taking part in a treatment study is up to you. It may be only
one of your treatment choices. Talk with your doctor. Together,
you can make the best decision for you
*If you do enter a study, you will be followed closely by doctors
and nurses throughout the research process
*If researchers learn that a treatment harms you, you will be
taken off the study right away. You may then receive other treatment
from your doctor.
*You have the right to withdraw from the study at any time,
and still receive care and treatment for your cancer.
One of your key rights is to INFORMED CONSENT. It means
that you must be given all the facts about a study before you
decide whether to take part. This includes details about the
treatments and tests you may receive and the possible benefits
and risks they may have. Your doctor will give you a form to
go over all the main facts. If you agree to participate, you
will be asked to sign the informed consent form. Signing the
consent does not mean that you must stay in the study. You may
withdraw at any time by notifying your doctor or nurse.
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QUESTIONS I SHOULD ASK
Finding answers and making choices may be hard for people with
cancer and those who care about them. It is important to discuss
your treatment choices with a cancer specialist (an oncologist).
Ask any questions you feel that you need to ask in order to
feel comfortable with your decision about treatment. Discussing
treatment options helps you to work better with your physician.
There is no question that is silly or foolish. Cancer specialists
know that you have a great deal of concern on your mind.
It might be helpful to take a friend or family member with you
when you go to the doctor to discuss treatment options. It is
also helpful to write down your questions and the answers you
receive. Some patients may use a tape recorder to help them
remember everything that was discussed. Below are some questions
you may want to ask your cancer specialist if you plan to consider
taking part in a clinical trial:
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What is the purpose of the study?
Why do researchers believe that the new treatment being tested
may be more effective? Has it been tested before?
Who sponsors the study, and who has reviewed and approved
the study?
How is the study data and patient safety being checked?
Where will study results and information go?
What are the possible short and long term risks, side effects,
and benefits to me?
Are there standard treatments for my type of cancer?
How do the possible risks, side effects, and benefits in
the study compare with standard treatment?
What kinds of treatments, medical tests, or procedures will
I have during the study? Will they be painful? How do they compare
with what I would receive outside the study?
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How often and for how long will I receive the treatment,
and how long will I need to remain in the study? Will there
be follow-up after the study?
Where will my treatment take place? Will I have to be in
the hospital? If so, how often and for how long?
How will I know if the treatment is working?
Will I be able to see my own doctor? Who will be in charge
of my care?
How could the study affect my daily life?
Can you put me in touch with other people who are in this
study?
What support is there for me and my family in the community?
Will I have to pay for any treatment, tests, or other charges?
What is my health insurance likely to cover?
Who can help answer any questions from my insurance company
or managed care plan?
As you make your treatment decisions, remember that you are
not alone. Your doctor and nurse, family, clergy, or other people
with cancer, and others who care about you can help and support
you.
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