What
is a Clinical Trial?
A Clinical Trial (or Clinical Study) is an investigation
in human subjects intended to discover the effects of an investigational
drug including the drugs safety and efficacy. Clinical
Trials are performed to learn the best ways to treat or
to prevent disease. Clinical Trials can test drugs, vaccines,
or medical devices.
Why
participate in a clinical trial?
Participants in Clinical Trials are an essential part
of medical research. By participating in a Clinical Trial,
you will gain access to investigational drugs, medical services,
and a potential improvement in your medical condition. Your
contribution could improve the lives of you and your loved
ones. You could play a vital role in the introduction of new
medical treatments into your community. You and other patients
in the future may benefit as a result of your participation.
Phases
Clinical Trials are done in stages, which are called phases.
Below are three phases you should know before you enroll in
a clinical trial:
- Phase
I
The primary purpose of Phase I studies is to establish
safety and tolerance of a drug in humans. Phase 1 trials
also attempt to determine the body's reaction to the drug.
Phase 1 trials are short term (up to 1 month) and involve
a small population of healthy human subjects. This is
the first time a drug is tested in people.
- Phase
II
The primary purpose of Phase II trials is to determine
the best dosage to be used in further testing, and to
begin testing for efficiency. Phase II trials are the
first studies that use subjects with the disease or condition
the investigational drug or device is intended to treat.
- Phase
III
Phase III trials compare the results of people taking
the new treatment with results of people taking standard
treatment (e.g., which group has better survival rates?
fewer side effects?). In most cases, studies move into
Phase III testing only after a treatment shows promise
in Phases I and II. Phase III trials
may include hundreds or thousands of people. Phase III
trials are conducted to gather long term safety and efficacy
data.
- Phase
IV
Phase IV trials are conducted after a drug has been
approved by the FDA. Phase IV trials
continue to monitor long term safety in large populations.
- If
new labeling or therapeutic indication is being sought,
the pharmaceutical company has to return to Phase
2 or Phase 3 clinical trials.
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