Basics
of Clinical Research
Basics of Clinical Research |
Current
Studies |
Glossary
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What are
Clinical Trials?
Clinical Trials are research studies
designed to answer specific
questions about medicines, devices,
vaccines, or new ways of using known
treatments. They are conducted at
hospitals, universities, and
doctor's offices and are the fastest
and safest way to prove which
treatments work best in patients.
Why is it
important?
Clinical trials are essential to the
development of new and potentially
life-saving mediations and
treatments. Before a medication is
approved for use in the U.S. by the
Food and Drug Administration (FDA),
it must undergo three phases of
clinical trials to assure its safety
and efficacy. Most importantly,
study participants are essential to
the development and release of
medications and treatments which are
likely to improve the quality of
life for millions of people across
the country and around the world.
What are
the risks/benefits to participating?
Participating in a clinical trial is
a great way to play an active role
in your own healthcare. You will
receive education about the latest
medical management for your
condition and may have access to
medications and treatments years
before they become accessible to the
public.
In the trials that have a placebo
group, you will be informed if there
is a possibility you will receive
placebo medication. Placebo is an
inactive pill, liquid, or powder
that has no treatment effect. It is
often called a "sugar pill" by
researchers and it is used in
comparison to the treatment being
tested to determine the treatment's
efficacy. Not every clinical trial
uses placebos; some provide every
participant with an active
medication. Also, if at any
time during a clinical trial you
feel your condition is worse, you
are free to withdraw from the study.
The same ethical and legal codes
that govern medical practice also
apply to clinical trials. Participants are protected by
federal regulations and every
clinical trial must be approved and
monitored by an independent
Institutional Review Board to ensure
that the risks are as low as
possible.
Are
there costs?
Study participants receive expert
medical care, including blood tests,
EKGs, x-rays, and more, at no cost
during the course of a study.

Is there
compensation?
At West Coast Clinical Trials, we
understand your time is valuable so
we provide study participants with
monetary compensation for their time
and travel
How
long do studies last?
Each study is for a specific amount
of time and the time varies by the
drug that is being tested.
There are four phases in the
life of the drug before the drug is
released to the public.
Phase
I:
A small group (few dozen) of
normal, healthy volunteers try a new
drug or treatment for the first time
to evaluate its safety, determine a
safe dosage range, and identify side
effects.
Phase II:
A larger group (few
hundred) of volunteers that have a
particular disease or condition try
the new drug to determine its
effectiveness and to further
evaluate safety and side effects.
Phase III:
This is usually the final
phase of testing before a drug is
approved by the FDA. Hundreds to
thousands of participants help in
providing the efficacy, risks, and
side effect information that is used
to determine how physicians will
prescribe the drug once it is
approved.
Phase IV:
Occasionally studies are
done after a drug has been released
to the public in order to gather
additional information to determine
a drug's optimal usage or to compare
it to other existing therapies. |