| Frequently
Asked Questions: |
What are clinical trials?
Who can participate in clinical
studies?
How do you enroll in a clinical trial?
How much will you know about the
clinical trial treatment?
How are trials conducted?
What types of clinical trials
are available?
What happens to the treatment after
the clinical trials?
Take time to think through your
options
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What are clinical trials?
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Cancer treatment clinical trials are research studies to find
better ways to treat cancer. It is important that men and women
of all ages and backgrounds take part in these studies so that
what is learned will help cancer patients now and in the future.
Clinical trials often compare the most accepted cancer
treatment (standard treatment) with a new treatment that doctors
hope will be better. During a trial, more and more information
is gained about a new treatment, its risks, and how well it may
or may not work.
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| Who can participate in clinical studies? |
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Each trial has a list of criteria for who can participate,
including age, sex and type of disease and its progression. Also
important is whether you've been treated for your condition.
Some studies are restricted to people who haven't started
treatment, while others focus on people who've tried other
options first.
Anyone can participate in a clinical trial if they meet the
criteria of that trial and wish to participate. Patients take
part in clinical trials for many reasons. Usually, they hope for
benefits for themselves. They may hope for a cure of disease, a
longer time to live, and/or a way to feel better. Often, they
want to contribute to a research effort that may help others.
The patients in a clinical trial are among the first to receive
new research treatments before they are widely available. All
patients in clinical trials are carefully monitored during a
trial and followed up afterwards. They become part of a network
of clinical trials carried out around the country.
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How do you enroll in a clinical trial? |
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Your doctor might recommend a clinical trial to you or you
might find out about a trial on your own. The National
Institutes of Health posts listings of thousands of clinical
trials online.
In Whatcom County, the Medical Oncologists and the Radiation
Oncologists participate with the following national cancer
clinical trials:
- CTSU
(Clinical Trials Support Unit)
- GOG
(Gynecologic Oncology Group)
Through Fred Hutchinson Cancer Research Center, we are able
to participate and register patients.
- SWOG
(Southwest Oncology Group)
We are 1 of more than 100 community centers in the United
States who can register patients to their adult cancer
clinical trials.
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NSABP (National Surgical Adjuvant Project for Breast and
Bowel Project)
It is through Fred Hutchinson Cancer Research Center that we
can participate in these clinical trials.
- RTOG (Radiation
Therapy Oncology Group)
We are 1 of 4 affiliate members of RTOG in the state of
Washington who can register patients to their clinical
trials.
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How much will you know about the
clinical trial treatment? |
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It's crucial that you have enough information about the study
and the treatment being investigated to make a well-informed
decision. To do this, the study facilitators provide what's
called an informed consent document, which contains all of the
information you'll need to know about the study before deciding
whether to participate. The information should include details
about the experimental treatments, tests that may be given, the
possible risks and benefits of the tests and experimental
treatments as well as information about any standard treatments
available for your condition.
Before starting a trial, you must sign an informed consent
form. This form explains what will happen during the trial and
the known risks and benefits of participating in it. The form
must explain this information in words you can understand.
Researchers aren't allowed to pressure you into signing up for a
trial if you prefer not to get involved.
Signing the informed consent form means you agree to
participate in the trial as explained by the researcher and
described on the consent form. If you later decide to leave the
study, you may do so at any time without any penalty.
If you have any questions about the trial, ask before you
agree to participate. Questions you might want to ask include:
- Who sponsors the study? Who has reviewed it and approved
it?
- What is the purpose of the study?
- Why do researchers believe the new treatment being
tested may be effective?
- How are the study data and patient safety being checked?
- What will be expected of you?
- Is it possible that you might receive a placebo?
- What benefits or risks can you expect if you take part
in this study?
- How long will the study last?
- What happens if your condition gets worse during the
study?
- What if you don't want to take part in the study? What
other treatment options do you have?
- Where will your treatment take place?
- What is my health insurance likely to cover?
- Will you need to pay for any part of the study,
including doctor visits and routine tests?
- How will your participation in the study affect your
daily life?
- What happens at the end of the study?
- Will you be told the results of the study? When?
- Who will know that you're participating in the study?
- Who can you contact if you have more questions?
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| How are trials conducted? |
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Clinical trials follow a scientific action plan (protocol).
The protocol explains what will be done in the study and why. It
outlines:
- Who may participate
- How many people will take part
- What the treatment plan entails
- The type and frequency of tests
- How the results will be measured
- The reasons why a study may be stopped
- The situations in which researchers may stop giving the
treatment to participants
- The likely or known side effects of the treatment
- The possible benefits of the treatment
The clinical trials that are offered through St. Joseph
Hospital are written by research groups and reviewed and
supported by the National Cancer Institute. In addition, an
institutional review board (IRB) reviews the protocol. The IRB
includes people from the community as well as health care
professionals. It reviews all protocols to be sure that
participants are treated humanely and ethically. The IRB also
discusses such issues as whether the likely benefit of the
treatment is worth its risk.
A data safety monitoring board also oversees the trial. This
board is composed of people who aren't involved in the
development or administering of the study. Every 6 months, they
review the data all the clinical trial sites have submitted
concerning participants' treatment and side effects. The data
safety monitoring board can step in and stop the study at any
time if members see the treatment has too many side effects or
if the treatment isn't helping. A trial can also be halted by
the data safety monitoring board if the treatment is proving to
be better than the standard treatment. It may be working so well
that it should be made available to people outside of the
clinical trial.
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What types of clinical trials are
available? |
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Before any treatment is tested in people, it must be proved
safe and effective in the laboratory or in animals - sometimes
called preclinical research. This usually takes four to five
years. When a treatment is tested in people, it always takes
place in distinct phases. Each phase has a different purpose.
Treatments being tested must go through the testing phases in
order, including:
Phase I Research
This is the first step in testing in humans. At this
stage researchers study:
- How much of the treatment to give
- How much the human body reacts to the treatment
- How much can be given safely
- The best way to give the treatment
- Any harmful effects
Earlier studies have often only been done in animals, so
the approach may pose some risks when first tried in humans.
Researchers try to minimize these risks by starting with
very small doses, and then increasing the dosage only if no
or minimal side effects occur. Only a limited number of
people who would not be helped by existing treatments are
included in these trials. Between 20 and 80 volunteers
typically participate in Phase I studies, which usually last
several months. About 70 percent of the drugs tested in
Phase I are successful and move on to the second phase of
research.
Phase II Research
This phase focuses on determining whether a new approach
works the way it's intended. For example, does it shrink a
tumor or improve the results of cancer-related blood tests?
Researchers also monitor you for common short-term side
effects that occur with the therapy. Some things aren't yet
known about the treatment, so risks are still present.
Several hundred people may participate in these studies,
which can last from several months to years. On average, 33
percent of the drugs tested in Phase II are successful and
move on to the third phase of research.
Phase III Research
This phase usually begins only after a treatment shows
promise in phases I and II. At this stage, you're often
assigned randomly to receive either the experimental
treatment or the standard treatment. This helps to avoid
bias in the results.
When no standard treatment exists for a cancer, some
studies compare a potential new treatment with a placebo - a
pill or liquid that looks like the new treatment but has no
active ingredients. Before you participate in any trial,
you'll be told whether a placebo will be involved. If you
agree to participate, you must be willing to take a chance
that you'll get the placebo and not the active treatment.
Neither you nor your doctor can control which you will
receive.
Phase III trials provide more information about the
safety of the experimental treatment and demonstrate whether
the standard or the experimental treatment group has better
survival rates and fewer side effects. These trials usually
include several hundred to several thousand people and last
from one to four years. Large trials make it easier to
estimate what would happen if the experimental treatment
were available to everyone with the condition. About 25
percent to 30 percent of drugs tested in Phase III are
successful and go on to the government for approval.
The Drug Development and Approval Process in the 1990s
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What happens to the treatment after the
clinical trials? |
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After the first three phases have been completed, the company
or researcher studying the treatment submits an application to
the Food and Drug Administration (FDA) asking permission to make
the experimental treatment available to the public. On average,
about 20 percent of treatments successfully make it through all
phases of research and are approved. Put another way, for every
100 ideas for new treatments, 20 eventually become standards of
care.
On average the approval process takes about a year, but it
can take several more. Some drugs are approved in a matter of
months. These drugs are considered priority drugs - drugs that
provide a significant advance in treatment for a
life-threatening condition. The FDA's goal is to rule on these
drugs no more than six months after they've been submitted for
approval.
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| Take time to think through your
options |
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Learning about your disease and trying to decide how to treat
it can leave you feeling overwhelmed. Decide whether to
participate in a clinical trial only after thinking about your
preferences and talking with those close to you, with your
doctor and with other health care professionals.
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| Web Resources: |
To learn more about clinical trials:
To learn more about your rights as a clinical trial
participant:
To find a clinical trial:
To learn more about National Cancer Institute
Sponsored Research Groups:
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