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Clinical Trials Demystified
It seems that every time you turn on
the television or open a magazine these days there is a
new drug being touted as the new miracle cure-all. This
is especially true of allergy and heartburn medications.
How do scientists and researchers know what works and
what does not work? Potential new drugs are first
thoroughly evaluated in the laboratory with computer
models. After this phase of testing is completed,
additional research is then performed on laboratory.
Eventually, the new drugs must be tested on human
beings. This is done in a process called a clinical
trial. It may sound as though a research facility is
being sued, but itís even more complicated than that.
It was in 1938 that the Federal Food, Drug and Cosmetic
(FDC) Act was passed which made evidence of safety
mandatory before marketing was possible. The Kefauver-Harris
Drug Amendment passed in 1962, required that a drugís
effectiveness, as well as its safety, had to be proven.
The Food and Drug Administration (FDA) makes the final
So what is the process? Clinical trials, also known as
investigational drug studies, are a carefully designed
research study to determine whether new treatments or
drugs are safe and effective. These trials involve using
people, but only after extensive laboratory and animal
testing show positive results.
Clinical trial protocol is a set of rules on which the
trial is based. Basic protocol consists of the following
Who may participate
Test, procedure, medication and dosage schedules
Length of study
Each clinical trial proceeds through four phases. In
Phase I, scientists test a small group of 20-80 people
for the first time. A procedure or drugís safety is
evaluated, a safe dosage range is determined, and side
effects are determined. In Phase II, the number of
participants is increased to 100-300, and safety and
effectiveness are further evaluated. Phase III increases
the amount of people tested to between 1000 and 3000.
Safety, effectiveness and side effects are again
monitored with special emphasis on safety. Phase IV
occurs after the drug or treatment has been marketed.
Information about their effect in various populations is
evaluated as well as any side effects associated with