Clinical Trials Research
What is a clinical trial? A clinical trial is
a method of testing different medications/treatments/products to
determine which ones are safe and effective. There is a difference
between being treated by your health care team and clinical trials.
The primary goal of a health care team is to help the patient stay
healthy. While a study participant's health is an essential part
of clinical trials, the primary goal is to find out which treatments
work for the most people.
Clinical trials can be funded by pharmaceutical companies, the
National Institutes of Health (NIH) and other funding sources. They
can be conducted at universities, doctor's offices and clinics.
The research services and research medications/products received
in most clinical trials should be free and in some clinical trials,
study participants get paid to be involved.
On the Long Road to Approval
Prior to the Food and Drug Administration (FDA) approving medications
for sale by pharmaceutical companies, experimental medications must
go through phases of testing to determine their safety and effectiveness.
Phase I Clinical Trials: determine safe dosage
levels of the medication/treatment/product being studied. The sample
size is small ranging from 10-20.
Phase II Clinical Trials: determine safety and
effectiveness of the medication/treatment being studied. There are
a greater number of participants with a sample size ranging from
a few dozen to a few hundred.
Phase III Clinical Trials: determine the long-term
benefits from the medication/treatment/product. There are a large
number of participants with a sample size ranging from a few hundred
to a few thousand participants. Once the medication/treatment/product
has gone through testing phases, the FDA licenses the ones that are
safe and effective. At this point the medication/treatment/ product
may be prescribed by your physician. Please note that not all drugs
go through all phases of testing before they receive approval from
the FDA and the ones that are determined as unsafe or ineffective
are not licensed.
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