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This is just a small list of Clinical
See your health care team to learn more about clinical trails and what
trials are available in your area.
What is a Clinical Trial?
Finding a Clinical Trial
Choosing a Clinical Trial
Who pays for clinical research?
Should you participate
in clinical research?
The purpose of a clinical trial is
to determine whether a new treatment option is safe, effective and a better
alternative to current standard care methods. Volunteer participation by women
of all races, ages and ethnicities is essential, if researchers are to find the
best treatment regimens.
is a Clinical Trial?
A clinical trial is a strictly monitored process.
Before a pharmaceutical company can initiate testing in human subjects in a
hospital or clinical setting, it must conduct extensive pre-clinical or
laboratory research. This research typically involves years of experiments in
animal and human cells. The compounds are also extensively tested in animals. If
this stage of testing is successful, a pharmaceutical company provides this data
to the Food and Drug Administration (FDA), requesting approval to begin testing
the drug in humans. This is called an Investigational New Drug application
Before enrolling in a clinical trial, you will undergo the informed
consent process. At this time, the investigator will explain the purpose of the
trial, its expected benefits, any possible risks or side effects, and what your
role will be. This is the time to ask questions! If you want to join the trial,
you must sign the informed consent documents. You can
leave a clinical trial at any time without penalty, even after signing the
Clinical trials have four distinct phases:
|Phase One trials
use a small number of human subjects to test a new treatment that has already
undergone rigorous testing on animals. Participants usually have advanced cancer
that hasnít responded to standard treatments. At this stage, researchers can
only predict outcomes and any possible side effects on humans. During Phase One
trials, investigators determine the most effective dosage and application
methods. Some cancer patients have seen improvement in Phase One trials.|
trials involve a larger group of patients, in which
researchers build on what they learned in Phase One. Because more subjects are
involved, investigators may discover less common side effects, and will continue
to evaluate the safety of the treatment.|
trials may involve over a thousand patients, often at several
medical institutions. During this phase, the study treatment is compared to
and/or combined with standard modalities (treatment methods). Some participants,
the "treatment group," are given the experimental treatment and others
in a "control group" are given the current standard treatment, so
researchers can compare outcomes in the two groups.|
trials occur after the treatment has been put on the market
to monitor effects of long-term usage, and how it affects certain population
groups. If dangerous side effects are found, the drug or treatment is taken off
a Clinical Trial
Clinical trial investigators are eager to recruit
study participants and use a variety of resources to get the word out.
your doctor or cancer specialist; they may know of clinical trials for which you
might be eligible.
your local newspaper for advertisements seeking study volunteers in your area.
national newspapers, magazines and journals for current and future research.
a pharmaceutical company developing new cancer drugs. They can refer you to
clinical trial sites.
the Internet to view hundreds of ongoing clinical trials involving many
types of cancer. Below are are a few other web sites that list ongoing clinical
Institute - Information about cancer research studies.
a Clinical Trial
National Institutes of Health, through its National Library of Medicine, has
developed ClinicalTrials.gov to provide patients, family members and
members of the public current information about clinical research studies.
CenterWatch - clinical trials listing
service, including some M. D. Anderson trials.
Before participating in a clinical trial, discuss
it with your doctor or cancer specialist. Make sure to get all the details of
the intended benefits and possible side effects before signing any consent
forms. You can leave a clinical trial at any time, and
will not be penalized for doing so.
Here are some issues to
consider before enrolling in a clinical trial:
trial investigators follow strict criteria to recruit study volunteers.
Recruitment forms list "inclusion criteria": things like disease type,
treatment status, medical history, age range, gender, ethnicity and other
factors necessary to join the trial. Forms may also list what investigators arenít
looking for, known as "exclusion criteria."
clinical trials offer no guarantees, scientists have a strong belief that the
study drug or treatment will provide benefits equal to or better than standard
care methods. If that is the case, study volunteers will be the first to receive
this new modality, and will continue to receive medical checkups to monitor
- the clinical trial process
is not risk-free. Study investigators have anticipated many of the side effects,
but not all can be known ahead of time. If a new treatment exhibits potentially
dangerous side effects, the trial is immediately discontinued and participants
receive follow-up care to ensure they were not harmed. Remember, most standard
cancer treatments do have side effects, which include nausea, hair loss and
compromised immune systems.
trials can last anywhere from a few weeks to several years. Some require
frequent clinic or hospital visits, which can interfere with your normal
routine; others only need monthly or quarterly monitoring. Some studies,
particularly Phase Three, are conducted at several locations, but if you donít
live near a trial site, you may have to consider long travel times or temporary
relocation to participate.
It is essential to
determine what your out-of-pocket expenses will be in a clinical trial before
enrolling! You may be responsible for some or all of the costs involved,
including blood work, X-rays, and other procedures. Sometimes, a biotechnology
or pharmaceutical company or other research grant will sponsor a clinical trial
and pay some, but usually not all expenses.
Note: Usually in Canada all costs are covered in a clinical trial. Some
clinical trials will even pay you to be in them. Check with the trial
You also need to call your health insurance
carrier or managed care provider to see whether they cover clinical trials.
Insurance companies may deny coverage if the treatment is considered
experimental, but they might pay if the study treatment is similar to something
the patient would receive outside a clinical trial.
The fees that are covered differ from country to
you participate in clinical research?
Patients considering participating in clinical research should talk about it
with their physicians and medical caregivers. They also should seek to
understand the credentials and experience of the individuals and the facility
involved in conducting the study.
How long will the trial last?
Where is the trial being conducted?
What treatments will be used and how?
What is the main purpose of the trial?
How will patient safety be monitored?
Are there any risks involved?
What are the possible benefits?
What are the alternative treatments besides the
one being tested in the trial?
Who is sponsoring the trial?
Do I have to pay for any part of the trial?
What happens if I am harmed by the trial?
Can I opt to remain on this treatment, even after
termination of the trial?
benefits of clinical trials include:
|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 other
treatment choices, you are taking an active role in a decision that affects your
|You have the chance to help others and improve cancer
|New treatments under study are not always better than, or
even as good as, standard treatment.|
|Even if a new treatment has benefits, it may not work for
|In a study, if you are randomly assigned to have 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 do not always
cover all patient care costs in a study.|
See your health care team to learn more about
clinical trails and what trials are available in your area.