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What is a clinical trial?
A clinical trial (also clinical research) is a research
study in human volunteers to answer specific health questions.
Carefully conducted clinical trials are the fastest and
safest way to find treatments that work in people and ways
to improve health. Interventional trials determine whether
experimental treatments or new ways of using known therapies
are safe and effective under controlled environments. Observational
trials address health issues in large groups of people or
populations in natural settings.
Why participate in a clinical trial?
Participants in clinical trials can play a more active role
in their own health care, gain access to new research treatments
before they are widely available, and help others by contributing
to medical research.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate.
The factors that allow someone to participate in a clinical
trial are called "inclusion criteria" and 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, a participant must qualify for
the study. Some research studies seek 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.
The criteria help ensure that researchers will be able to
answer the questions they plan to study.
Who sponsors clinical trials?
Clinical trials are sponsored or funded by a variety of
organizations or individuals such as physicians, medical
institutions, foundations, voluntary groups, and companies,
in addition to federal agencies such as the National Institutes
of Health (NIH), the Department of Defense (DOD), and the
Department of Veteran's Affairs (VA). Trials can take place
in a variety of locations, such as hospitals, universities,
doctors' offices, or community clinics.
What is informed consent?
Informed consent is the process of learning the key facts
about a clinical trial before deciding whether or not to
participate. It is also a continuing process throughout
the study to provide information for participants. To help
someone decide whether or not to participate, the doctors
and nurses involved in the trial explain the details of
the study. Then the research team provides an informed consent
document that includes details about the study, such as
its purpose, duration, required procedures, and key contacts.
Risks and potential benefits are explained in the informed
consent document. The participant then decides whether or
not to sign the document. Informed consent is not a contract,
and the participant may withdraw from the trial at any time.
To help you make educated decisions about participating
in a clinical trial and for additional information about
clinical trials, go to http://www.clinicaltrials.gov/ct/info/resources.
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