What is a clinical trial?
Clinical trials are research studies that involve people
through clinical trials. Doctors find new ways to improve
treatments and the quality of life for people with disease.
Often a clinical trial is used to learn if a new treatment is
more effective and Oregon has less harmful side effects than
the standard treatment.
Researchers designed cancer clinical trials to test new ways
to treat cancer, find and diagnose cancer, prevent cancer,
and manage symptoms of cancer and side effects from its
treatment.
A clinical trial is the final step in a long process that
begins with research in a lab.
Before any new treatment is used with people in clinical trials,
researchers work for many years to understand its effects on
cancer cells in the lab and sometimes in animals. They also
try to figure out the side effects it may cause.
Some clinical trials test ways to find a disease early,
sometimes before there are symptoms, still others test ways
to prevent a health problem.
A clinical trial may also look at how to make life better for
people living with a life threatening disease or a chronic
health problem.
Clinical trials sometimes study the role of caregivers or
support groups.
There are several types of cancer clinical trials,
including prevention trials, screening trials, treatment
trials, and quality of life trials.
Cancer prevention trials are studies involving healthy
people.
In most prevention trials, the people who take part either do
not have cancer but are at high risk for developing the disease
or have had cancer and are at risk for developing new cancer.
These studies look at cancer risk and ways to reduce that
risk.
The goal of cancer screening trials is to test new ways to
find the disease early, when it may be easily treated.
An effective screening test will reduce the number of deaths from
the cancer being screened.
Researchers who conduct cancer screening studies want to know?
Does finding disease earlier before people have any symptoms
save lives?
Is 1 screening test better than another?
Do large numbers of people who receive the screening test
undergo unnecessary follow-up tests and procedures?
Most cancer clinical trials are treatment studies that involve
people who have who have cancer.
These trials test new treatments or new ways of using existing
treatments.
Such as new drugs, vaccines, approaches to surgery or
radiation therapy, and combinations of treatments,
including some that work to boost your immune system to help
fight the cancer.
Treatment trials are designed to answer questions such as.
What is a safe dose of the new treatment? How should the new
treatment be given? Does the new treatment help people with
cancer live longer?
Can the new treatment shrink tumors or prevent them from
growing and spreading to new places in the body?
Does the treatment allow a better quality of life with
fewer side effects or help the treatment?
Or help prevent the cancer from coming back once treatment is
finished.
Quality of life or supportive trials look at ways to improve
the quality of life with cancer patients, especially those who
have side effects from cancer and its treatment.
They find ways to help people cope with pain, nutrition
problems, infection, depression and other health problems.
These trials also might test activities such as attending
support groups, exercising, or talking with a counselor.
Some trials test ways to help families and caregivers cope
with their own needs as well as those of the person with cancer.
Why are clinical trials important today? People are
living longer lives from successful cancer treatments
that the result of past clinical trials.
Through clinical trials, researchers and doctors
determined whether new treatments are safe and
effective and work better than current treatments. Clinical
trials also help us find new ways to prevent and detect
cancer.
When someone takes part in a clinical trial, they add to our
knowledge about cancer and help improve cancer care for future
patients. Clinical trials are the key to making progress
against cancer.
These and many other common beliefs about clinical trials
are simply not true.
Myth number one. Study participants are given placebo
or a sugar pill. A placebo is a pill or liquid that does not
contain any medication.
Researchers never use sugar pills in place of the best known
treatment for a given cancer.
Patients who dream who join clinical trials will never
sacrifice quality of care.
In prevention studies, it is possible to get a placebo.
Treatment studies compare new treatment to a standard
treatment. Sometimes a standard treatment plus new treatment is
compared to the standard treatment plus the placebo.
Myth #2.
Study participation or is for people without options.
Sometimes clinical trials can be a last resort, but many times
they simply involve a simple addition or adjustment to a
standard treatment plan that can provide patients with a better
quality of life or treatment options that may prove to be
better than or boost the effectiveness of the standard of
care.
Clinical trial participation is for patients who have not yet
been treated. For those whom standard treatments have not yet
worked, and for those seeking different alternative care
options.
Myth #3.
Once people begin participation, they have to stay in the study.
In view of historical abuses and laws in place to minimize
abuses, it is it is important to note that every study
participant can choose to withdraw even after having
initially agreed to participate.
At that point their doctors can switch to the standard treatment
for their condition. Myth number 4 you will not be a Guinea pig,
but it's true that the purpose of a clinical trial is to answer
a medical question.
People who take part in clinical trials may need to do extra
things or have certain tests done as part of the clinical
trial, but this does not mean that you won't get excellent
care while in the study. In fact, most people enrolled in
clinical trials welcome the extra attention that they get
from their cancer care team.
You may ask yourself why should I try something that researchers
are not sure will work. That's a good question. Being part of a
clinical trial may have risks, but may also have benefits.
Some benefits of participating are an opportunity to play a
more active role in your health. You may learn and adopt healthy
behaviors that you did not have before.
You may get a new treatment for a disease before it is available
to everyone.
And you may have the chance to help others get a better
treatment for their health problems in the future.
We will now go over some of the possible risks of clinical trial
participation.
The new treatment may not work or it may not be better than the
standard treatment.
The clinical trial could inconvenience you. For example,
medical appointments and tests could take a lot of time.
The new treatment may cause side effects or be uncomfortable.
In some trials, participants may not get individual results. It
depends on the type of the trial.
Before deciding to participate, carefully consider risks and
possible benefits. Remember, a member of the research team will
explain the study and answer any questions you might have. The
specific risks associated with a research protocol are described
in detail in the informed consent document, which
participants are asked to consider & before participating
in research.
The goal of a clinical trial is to determine if these treatment,
prevention, and behavior approaches are safe and
effective.
We do so by following an approved plan known as a
protocol. A protocol is a plan that explains how the trial will
work, what will be done during the trial, and why.
Key information in a protocol includes the purpose of the
study, who can participate, how many patients will participate,
what tests patients will get, and how often.
What type of data will be collected?
To make sure that participants are safe, researchers are
required to follow strict rules.
These rules are enforced by the federal government. As part of
this process, an Institutional Review Board or IRB's at each
study site must be approved. Every clinical trial in the
United States. The IRB is made up of doctors, scientists and
people like yourself who are dedicated to making sure that
the participants are not exposed to any unnecessary risks.
They make sure that the risks or potential harm to participants
are as low as possible.
The Institutional Review Board we just discussed is one of the
ways safeguards are in place to protect the health and safety of
participants.
There are other federal rules in place to help ensure the safety
and ethics of clinical trials.
Patients are protected through the informed consent process.
Careful review and approval of the clinical trial protocol by
scientific experts and the IRB and ongoing monitoring of the
trial.
Protection of patient health and safety also means research
studies must take steps to ensure that your health
information remains confidential.
Lastly, researchers have a moral obligation to protect
participants and treat them humanely and ethically.
The informed consent process also helps protect participants.
Before joining a clinical trial, patients will be told what to
expect as a participant and all the things that may happen. For
example, someone from the research team will explain
possible side effects or other risks of the treatment.
As part of the informed consent process, a patient will have a
chance to ask questions about the trial both before they
choose to join the study as well as while they're in the study.
After getting all this information, a patient can think
about whether or not they would like to participate.
During the informed consent process, the research team first
explains the purpose, procedures and the risks and benefits.
They will discuss the rights, including the right to make a
decision about taking part or to leave the study at any time.
Before agreeing to take part in a trial, patients have the right
to learn about all treatment options. Learn all that is
involved, including details about treatment tests and
possible risks and benefits.
Both hear and read the information in language they can
understand.
If the patient decides to join the trial, they will be giving
an informed consent to sign. But even after a participant signs
the consent form, they can leave the study at any time.
It is important for clinical trials to include people from
all backgrounds as all populations of people
experience, illness and disease.
Gender, race, ethnic origin, age, weight, and even where you
live can lead to different responses to the same medication
or treatment.
When medications are treatments are studied in only one group,
doctors will not know whether they are safe and or effective
for everyone.
If a patient is thinking about joining a clinical trial, the
best place to start is to talk with their doctor or another
member of the health care team.
He or she may be able to search for a trial, provide
information, and answer questions to help decide about
joining a clinical trial.
If a patient decides to look for trials on their own, the NCI's
Cancer Information Service can provide tailored clinical trial
search that can be discussed with the patient's doctor.
That service can be utilized by either calling one 800 for
cancer or at clinical trials Gov.
If you are thinking about taking part in a clinical trial, be
sure to ask your doctor. Is there a clinical trial that I
can join?
Lastly, while joining a clinical trial might be scary, as you do
not know how your body will react to a new treatment,
conducting research in very organized, detailed methods is
our best hope for advancing treatment and eventually finding
a cure for cancer.