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About
Clinical Research:
Who
benefits from clinical research?
-
Patients
- gain access to new, alternative therapies that may be better
than the standard treatment. Also, the health status of
patients enrolled in clinical trials is carefully monitored.
-
Physicians
and Researchers - Medical researchers gain new insight into
drugs, devices, and techniques to fight disease and improve the
quality of life.
-
Everyone
- Society as a whole benefits from clinical research as
researchers share their findings.
How are
experimental treatments testing in people?
When testing a new drug
or medical intervention, clinical research progresses in an
orderly series of phases. By obtaining information in this
sequential manner, researchers are able to rigorously test their
specific hypotheses and protect patients from potential risks.
There are usually four
phases.
-
Phase
I - evaluate how a new
drug or treatment should be given (orally, intravenously, etc.),
how often, what dose is safe, and if there are any side effects.
A Phase I trial usually enrolls only a small number of patients
(20-80).
-
Phase
II - continue to test the
safety of the intervention, and begin to evaluate how well the
new intervention works. A Phase II trial enrolls a larger
group of people (100-300)
-
Phase
III - test the new
intervention in comparison to the current standard for
treatment. Phase III trials often enroll large numbers of
people (1,000 - 3,000) and may be conducted at many clinics and
medical centers nationwide.
-
Phase
IV - continue to test the
effectiveness of the intervention and the long-term consequences
associated with its use. A Phase IV trial is conducted
after the new drug or treatment has met federal approval and is
marketed.
Who pays
for clinical research?
-
The federal
government (e.g., Centers for Disease Control and
Prevention, National Institutes of Health)
-
Private
industry (e.g., a pharmaceutical company)
-
Voluntary health
agencies (e.g., National Kidney Foundation, American
Heart Association)
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