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Answers to Exercises
Answers to Exercise 1.1
Answers to Exercise 1.2
Answers to Exercise 2
Answers to Exercise 3
Answers to Exercise 4
Answers to Exercise 5.1
A. Cancer treatment clinical trials are the treatment of last
resort.
Clinical trials are not only for those with the most
advanced disease. Phase 3 treatment trials, for example, can
include people who have all stages of disease, from the most
advanced to people newly diagnosed who have very limited disease.
B. Only people who have cancer are eligible to participate in a
cancer clinical trial.
Three types of cancer trials are open to people without
cancer. Prevention trials study ways to prevent cancer in people;
early detection/screening trials look at ways to detect cancer as
early as possible; and diagnostic trials focus on ways to test for
or better identify cancer.
C. Many people who join cancer treatment clinical trials get a
sugar pill (placebo) instead of being treated.
Placebos are rarely used in cancer treatment trials. No
one is ever given a placebo when an effective treatment is
available. However, in rare cases, a placebo may be used when
testing a new drug if there is no known effective treatment.
D. By restricting who can go on trials, investigators keep people
from getting a new treatment that could save their lives.
There are important reasons that clinical trials have
eligibility criteria:
To protect the particpant's safety. Some people have other health problems that could be made worse by the treatments in a study.
To ensure study results are accurate and meaningful. The trial participants need to be as similar as possible so that doctors can be sure of the reasons for the results. For example, if a participant already had another kind of treatment, the patient's response may reflect the earlier treatment rather than the one being studied.
Remember, no one knows whether the treatment being tested in a clinical trial will turn out to be better than the approaches currently being tested.
A. What type of trial is this?
Treatment trial
B. What phase trial is this?
It is a phase 3 trial because the description says it is
not yet known whether combination chemotherapy plus trastuzumab is
more effective than combination chemotherapy alone for treating
breast cancer. The combination chemotherapy is considered standard
treatment.
C. Is it randomized?
Yes. It says patients will be randomly assigned to one of
two groups.
D. If someone meets the eligibility requirements, what kind of
person might be interested in participating?
Someone who:
Is willing to attend many chemotherapy treatment
sessions
Understands that she has an equal chance of being
assigned to either group
Is willing to be followed for several years
Is interested in contributing to scientific
knowledge
E. What might be of concern for someone considering participating
in this trial?
People will not be able to select the group they
would like to participate in
Participants must agree to be followed for several
years
People will want to know how the protocol determines who
will need to:
A. What happens to clinical trial results?
After a clinical trial is completed, researchers look
carefully at the collected data before making decisions about
further testing and what their findings mean.
After a phase 1 trial is completed, researchers decide
whether:
After a phase 2 trial is completed, researchers decide
whether:
After a phase 3 trial is completed, the researchers must look
at the data and decide whether the results have medical
importance. When the analysis is complete, the researchers will
inform the medical community and the public of thetrial
results.
In most cases, a trial's results are first reported in
peer-reviewed scientific journals. But if a trial's results have
significant medical importance for people with cancer, a public
announcement may be made while the formal report is being
submitted to ensure that people can quickly benefit from the new
advance. Particularly important results are likely to be featured
by the media and widely discussed at scientific meetings and by
advocacy groups.
Once an intervention is proven safe and effective in a clinical
trial, it may become the new standard of practice for
physicians
B. Clinical trials answer research questions. How does this help
people?
Clinical trials do more than just answer research
questions. Clinical trials are initiated because we don't yet know
whether one treatment is better than another. Most of today's
treatments for cancer are based on the results of earlier clinical
trials. Clinical trials have also resulted in many new treatments
and prevention options for cancer care.
C. Sometimes researchers decide not to continue studying an agent
or to seek FDA approval. How do scientists decide when to move from
one clinical trial phase to the next?
Clear "yes" or "no" answers are rare in science. It is
particularly difficult to decide what is worth pursuing and what
is not when the data are unclear. Researchers make decisions based
on scientific evidence, which is why research moves in such slow
and careful steps. Even if some participants in a clinical trial
have a positive response to the new treatment, researchers must
look at the experience of all participants when deciding whether
to continue trials. For example, more people treated with the
standard therapy may have better results than those treated with
the experimental treatment.
D. How can public awareness about clinical trials influence the
research process?
With increased public awareness about clinical trials, more
people may be willing to participate. With a greater pool of
participants, researchers can complete the trial more quickly and
speed the development of new treatments.
E. How do clinical trials differ from unsound or alternative treatments?
Clinical trials sponsored by NCI and other reputable agencies evaluate new treatments for safety and possible benefit via IRB-approved protocols.
Complementary and alternative medicine, as defined by the National Center for Complementary and Alternative Medicine (NCCAM), is a group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine. The list of complementary and alternative medicine practices changes continually, as those therapies that are proven safe and effective become adopted into conventional health care and new approaches to health care emerge.
Neither new treatments tested in clinical trials nor untested alternative treatments are known to be effective when they are initially given.
Alternative treatments that have not been carefully studied may be harmful.
Many CAM practices are now being evaluated within protocols for their effectiveness and safety. For more information, visit nccam.nih.gov.
Other terms for CAM include unconventional, non-conventional, unproven, and irregular medicine or health care.
A. Aren't people who join clinical trials just "guinea pigs" for
research?
Many safeguards are in place for people who join cancer
trials. All clinical trial participants go through the informed
consent process. Informed consent is an ongoing process in which
people learn important information about a clinical trial. This
information helps them decide whether to participate.
The trial is also monitored by an institutional review board
(IRB) and, if the study is a phase 3 clinical trial, by a data and
safety monitoring board (DSMB).
In response to breaches in protection that have been recently
identified and reported in the media, in 2000, the U.S. Department
of Health and Human Services took additional steps to strengthen
Government oversight of medical research and to reinforce clinical
researchers' responsibility to follow guidelines.
B. Can a person be put in a clinical trial without his or her
knowledge?
No. The researchers running the trial are required by law
to present and explain the study as part of the informed consent
process. This process includes:
Signing of an informed consent document (so that people know they are entering a study)
Discussing with the research team what the trial entails
Understanding the potentials risks and
benefits of participating.
Although reputable researchers do not fool people or sign them
up against their will, sometimes people have difficulty
understanding the information they need about a trial before
agreeing to join. For many people, it is important to ask a friend
or family member to come with them when they receive information
about medical options to be sure that all important questions are
raised. Taking notes or using a tape recorder can also help.
C. If someone is in a phase 3 trial and it is found that there is
a clear advantage for the participants in the other group, what
happens?
The DSMB would be monitoring the study and would report
the information to the study sponsor. If early results show that
there is a clear advantage for one of the groups, the sponsor of
the study may choose to end the trial early and establish a
protocol allowing wider use of the drug before final approval for
marketing.
D. What happens if someone wants to stop participating in a
trial?
Under the informed consent process, a person has the
right to discontinue their participation in a trial at any time. A
participant's decision to leave a clinical trial does not
jeopardize future treatment, and the participant will have the
chance to discuss other treatments, or care with a doctor from the
trial. The person may be referred back to his or her primary
doctor for standard care.
A. Do doctors discuss clinical trials as options for their patients?
Health care professionals may not discuss clincial trials with their patients for the following reasons:
They are not aware of clinical trials
They are unwilling to lose control of a person's care
They believe that standard therapy is best
They cannot find a trial which is compatible with the person's clinical situation
No matter what the situation, people with cancer have the right to consider all possible treatment options before deciding which treatment option is right for them.
B. If a doctor cannot or will not refer a person to a clinical trial, can the person or family make the call themselves?
Decisions about eligibility for a trial can be complicated and require very specific medical information on a person's condition. Therefore,
It is preferable to have the contact made by a health care professional familiar with the case
Participants calling researchers directly may not have all the information needed to make eligibility decisions
If a physician is unwilling to make contact with clinical trial investigators, the best alternative may be to request a referral to another physician
C. Is it more expensive to participate in a clinical trial compared to standard treatment? Are clinical trials covered by insurance?
There are two kinds of costs associated with clinical trials:
Patient care costs
May be covered by a person's health plan
Include usual care cost items like doctor visits, hospital stays,
clinical laboratory tests, and x-rays, which occur whether someone
is participating in a trial or receiving standard treatment
Research costs
Some health plans cover the costs associated with clinical trial participation; other
companies will not reimburse costs for "experimental therapies"
Decisions are usually made on a case-by-case basis
Some clinical trial sponsors work with health plans to get
reimbursement
People interested in clinical trial participation should ask the trial team what their experience
with reimbursement for this trial has been
Clinical trial participants may also contact NCI's Cancer Information
Service at 1-800-4-CANCER or visit the clinical trials section of
www.cancer.gov, for information on organizations that may help with clinical
trials coverage
D. Are chemoprevention trials covered by insurance? If so, will participants compromise their coverage by entering trials for those at "high risk" for cancer?
There is no comprehensive data on insurance problems related to entering a chemoprevention trial, but some issues have been reported:
Participants receive prevention agents free of
charge
Coverage for medical tests can be an issue
Some institutions will pay for the initial test, but not all
If a re-test is needed it may not be covered, especially if it has not been authorized by the primary care gatekeeper
Prevention trials may require more frequent screening exams (such as mammograms or colonoscopy), and insurers may not want to cover a test given more frequently than their guidlines require (for example every six months versus every year)
Many insurance companies have policies on "pre-existing conditions," so entering a trial for those at "high risk" could make it harder or more expensive to get health and life insurance in the future
Some states have laws about pre-existing conditions and Federal law forbids companies to deny health care to people with pre-existing conditions. It remains unclear how insurers will handle "high risk" conditions.
Participants may contact NCI's Cancer Information
Service at 1-800-4-CANCER or visit the clinical trials section of
www.cancer.gov for information on organizations that help with clinical trials coverage and insurance questions.
Decisions concerning eligibility for clinical trials may be
complicated, often requiring very specific medical information on the
person's condition. For that reason, it is usually preferable to have
the contact made by a doctor familiar with the case.
Often, potential participants making calls directly may have
insufficient information, which may make decisions about eligibility
difficult and frustrating both for the person making the calls and
for the researcher taking the calls.
Depending on the institution, a referral coordinator, protocol
assistant, or nurse may accept telephone, mail, and e-mail inquiries
from physicians, potential participants, and others about the
clinical trial. Preliminary eligibility can be evaluated by phone,
and appointments with the clinical trial team can be scheduled.
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