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Clinical Trials
Volunteering Your Body For Cancer Research
Clinical
Trials | How? | Where? | What?
Why?
Describes why one should participate in a clinical trial.
Why are there clinical trials?
A clinical trial is one of the final stages
of a long and careful cancer research process. Studies are done with cancer
patients to find out whether promising approaches to cancer prevention,
diagnosis, and treatment are safe and effective.
Why Are Clinical Trials Important?
Clinical trials are
important in two ways.
First, cancer affects us all, whether we have
it, care about someone who does, or worry about getting it in the future.
Clinical trials contribute to knowledge and progress against cancer. If a
new treatment proves effective in a study, it may become a new standard treatment
that can help many patients. Many of today's most effective standard treatments
are based on previous study results.
Examples include treatments for breast, colon,
rectal, and childhood cancers.
Clinical trials may also answer important
scientific questions and suggest future research directions. Because of progress
made through clinical trials,
many people
treated for cancer are now living longer.
Second, the patients who take part may be helped personally by
the treatment(s) they receive. They get up-to-date care from cancer
experts,
and they receive
either a new treatment being tested or the best available standard treatment
for their cancer. Of course, there is no guarantee that a new treatment
being tested or a standard treatment will produce good results.
New treatments
also may have unknown risks. But if a new treatment proves effective
or more effective
than standard treatment, study patients who receive it may be among the
first to benefit. Some patients receive only standard treatment
and benefit from
it. In the past, clinical trials were sometimes seen as a last
resort for people
who had no other treatment choices. Today, patients with common cancers
often choose to receive their first treatment in a clinical trial.
Should I Take Part in a Clinical Trial?
This is a question only you, those close
to you, and your health professionals can answer together. Learning you
have cancer and deciding what to do about it is often overwhelming.
This
section has information you can use in thinking about your choices
and making your decision.
Clinical Trials: Weighing the Pros and Cons
While a clinical trial is a good choice
for some people, this treatment option has possible benefits and drawbacks.
Here are some factors to consider. You may want to discuss them with your
doctor and the people close to you.
| Potential
Benefits |
Potential
Risks |
| Health care provided by leading
physicians
in the field of cancer research. |
New drugs and procedures may
have side
effects or risks unknown to the doctors. |
| Access to new drugs and interventions
before they are widely available. |
New drugs and procedures may
be ineffective,
or less effective, than current approaches. |
| Close monitoring of your health
care
and any side effects. |
Even if a new
approach has benefits, it may not work for you. |
| A more active
role in your own health care. |
|
| If the approach being studied
is found
to be helpful, you may be among the first to benefit. |
|
| An opportunity
to make a valuable contribution to cancer research. |
|
Talk
with your doctor. Together, you can make the best choice for you. If you
do enter a study, doctors and nurses will follow your response to treatment
carefully throughout the research. 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 own doctor. You have the right to leave a study
at any time.
One of your key rights is the right to informed consent.
Informed consent 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. The
doctor or nurse will give you an informed consent form that goes over
key facts. If you agree to take part in the study, you will be asked
to sign this informed consent form. The informed consent process continues
throughout the study. For instance, you will be told of any new findings
regarding your clinical trial, such as new risks. You may be asked to
sign a new consent form if you want to stay in the study. Signing a
consent form does not mean you must stay in the study. In fact, you can leave
at any time. If you choose to leave the study, you will have the chance
to discuss other treatments and care with your own doctor or a doctor
from the study.
Human
Participants Protection Education for Research Teams
This tutorial is intended for use by those involved
in the design and conduct of research involving human participants, including:
Biomedical and behavioral researchers, Nurses and data managers who are
part of the research team.
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Copyright © SURVIVOR ~ Breast Cancer Stage IV 2001 ~ 2006
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