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What
is a Clinical Trial?
Clinical trials are research studies in which people help doctors find ways to
improve health and cancer care. Each study tries to answer scientific questions
and to find better ways to prevent, diagnose, or treat cancer.
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.
What
are the different types of clinical trials?
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Treatment trials
test new treatments (like a new cancer drug, new approaches to surgery or
radiation therapy, new combinations of treatments, or new methods such as gene
therapy).
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Prevention trials
test new approaches, such as medicines, vitamins, minerals, or other supplements
that doctors believe may lower the risk of a certain type of cancer.
These trials look for the best way to prevent cancer in people who have
never had cancer or to prevent cancer from coming back or a new cancer occurring
in people who have already had cancer.
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Screening trials
test the best way to find cancer, especially in its early stages.
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Quality of Life
trials (also called Supportive Care trials) explore ways to improve
comfort and quality of life for cancer patients.
What
are the phases of clinical trials?
Most
clinical research that involves the testing of a new drug progresses in an
orderly series of
steps, called phases.
This allows researchers to ask and answer questions in a way that results in
reliable information about the drug and protects the patients. Clinical trials
are usually classified into one of three phases:
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Phase
I trials: These
first studies in people evaluate how a new drug should be given (by mouth,
injected into the blood, or injected into the muscle), how often, and what ose
is safe. A Phase I trial usually enrolls only a small number of patients,
sometimes s few as a dozen.
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Phase
II trials: A phase
II trial continues to test the safety of the drug, and begins to evaluate how
well the new drug works. Phase II studies usually focus on a particular type of
cancer.
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Phase
III trials: These
studies test a new drug, a new combination of drugs, or a new surgical procedure
in comparison to the current standard. A participant will usually be assigned to
the standard group or the new group at random (called randomization).
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Phase III trials often enroll large numbers of people and may be conducted at many doctors'
offices, clinics, and cancer centers nationwide.
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