|
What is a clinical trial?
(top)
All new investigational treatments must be tested to determine if they are safe and useful. New
investigational treatments are tested on people in research studies called clinical trials. Clinical
trials are a way to help find future treatments. Clinical trials are done in a
careful, organized manner, according to a set written plan called a “protocol”. When
conducted successfully, clinical trials are the standard by which we evaluate all
new investigational procedures and treatments for diseases. All new investigational treatments must pass their
clinical trials before they can be evaluated by the Food and Drug Administration
(FDA) for possible approval. This is an agency of the U.S. government.
Why participate in a clinical trial?
(top)
By participating in a clinical trial you can learn more about your
own health, gain access to new research treatments that are not otherwise
available, and help others in the future by contributing to medical research. There is no
guarantee that you will benefit from participating in this trial.
There may be risks involved in participating in a clinical
trial. Some of these risks may be known while others may not. There may also be
side effects from the study treatment being tested. Not all side effects may be
known.
Who can participate in a clinical trial?
(top)
All clinical trials have guidelines about who can participate. Using
inclusion/exclusion criteria is an important principle of medical research that
helps to produce reliable results. The factors that allow someone to
participate in a clinical trial are called "inclusion criteria". Those that
disallow someone from participating are called "exclusion criteria". These
criteria are based on such factors as age, gender, the type and stage of a
disease, previous treatment history, and other medical conditions. Before
joining a clinical trial, you must qualify for the study. Some research studies
look for participants with illnesses or conditions to be studied in the
clinical trial, while others need healthy participants. It is important to note
that inclusion and exclusion criteria are not used to reject people personally.
Instead, the criteria are used to identify appropriate participants and keep
them safe.
What is informed consent?
(top)
Informed consent is the process of learning the key facts about a clinical
trial before you decide to participate. It is also a continuing process
throughout the study to provide information for participants. To help you
decide whether or not to participate, the doctors and nurses involved in the
trial will explain the details of the study. The research team will then
provide you with an informed consent document to read. The document includes
details about the study, such as its purpose, duration and required procedures.
Risks and potential benefits are also explained in the informed consent
document. After you have received and read all the information about the study,
you will then decide whether or not to sign the document. The informed consent
document is not a contract, and you may withdraw from the trial at any time.
How is my safety protected?
(top)
The ethical and legal codes that govern medical practice also apply to clinical
trials. In addition, most clinical research is federally regulated with built
in safeguards to help protect the participants. The trial follows a carefully
controlled protocol, a written study plan which details what researchers will do in the
study. As a clinical trial progresses, researchers report the results of the
trial at scientific meetings, to medical journals, and to various government
agencies. Individual participants' names will remain secret and will not be
mentioned in these reports.
How are my rights protected?
(top)
Every clinical study in the U.S. must be reviewed and approved
by an Institutional Review Board (IRB). An IRB is an
independent committee of physicians, statisticians, community advocates, and
others that helps to ensure that a clinical trial is ethical and that your rights are
protected. All institutions that conduct or support biomedical research
involving people must, by federal regulation, have an IRB that initially
approves and periodically reviews the research.
What should I consider before participating in a trial?
(top)
You should know as much as possible about the clinical trial before deciding to
participate. You should ask the members of the study team questions about
the trial, the care expected while in the trial, and the cost of the trial. The
following questions might be helpful to discuss with your study team.
Some of the answers to these questions are found in the informed consent
document that you will receive from the study nurse or doctor.
-
What is the purpose of the study?
-
Who is going to be in the study?
-
Why do researchers believe the new investigational treatment being tested may or may not be effective?
-
Has the study treatment been tested before?
-
What kinds of tests and treatments are involved?
-
How do the possible risks, side effects, and benefits in the study compare with
my current treatment?
-
How might this trial affect my daily life?
-
How long will the trial last?
-
Will hospitalization be required?
-
Who will pay for the treatment?
-
Will I be reimbursed for other expenses?
-
What type of long-term follow up care is part of this study?
-
How will I know that the study treatment is working?
-
Will results of the trials be provided to me?
-
Who will be in charge of my care?
What should I think about before meeting with the study
doctor? (top)
-
Plan ahead and write down possible questions to ask.
-
Ask a friend or relative to come along for support and to hear the responses to
the questions.
-
Bring a tape recorder to record the discussion to replay later.
Will my primary health care provider still treat me while I
am in the study? (top)
Yes. Most clinical trials provide short-term study-related care related to a designated
illness or condition, but do not provide extended or complete primary health
care. In addition, by having your health care provider work with the research
team, you can ensure that other medications or treatments will not conflict
with the study treatment.
Can I leave a clinical trial after it has begun?
(top)
Yes. You can leave a clinical trial, at any time.
What are the phases of clinical trials?
(top)
Clinical trials are conducted in phases. The trials at each phase have a
different purpose and help scientists answer different questions:
Phase I: The investigational treatment is first given to or
performed on a small number of healthy people (without disease or illness). About 20 to 100 people
get the treatment at this stage. Study doctors look to see how much of the study treatment is safe
to take and how the human body is affected when it gets the treatment.
Phase II: At this stage, doctors look to see
if the study treatment is useful and safe. Can it help the disease or illness it was
designed to treat? Doctors also look at which dose works best. About 100 to 500
subjects with the disease or illness get the study treatment at this stage.
Phase III: At this stage, study doctors look to see
if the study treatment is still useful in treating a disease or illness. They also
look to see if there are side effects over a longer time period. Between 1000
and 5000 subjects get the study treatment at this stage.
For Varisolve®, Phase II has been completed.
|