What Are Clinical Trials?
A clinical trial is a drug study
sponsored by a pharmaceutical or biotechnology company.
There are cases, however, where health-related
government agencies provide funding and other resources
for a clinical trial. The purpose of these studies is to
find out whether a medication is safe to use and
effective against various diseases or medical
conditions. In order to study the medication, several
questions need to be answered first. For example, what
patient population or disease is the drug meant to
treat? What criteria should be used for accepting
participants into the study? What general and
disease-specific information are the study doctors going
to obtain? Essentially, once these and other important
study questions are answered, the study doctors
(investigators) are chosen, the regulatory documents are
approved, and the study is ready to begin.
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Why are clinical trials
important?
There are a several reasons why clinical trials are important.
First, the participant may have a positive response to the
study medication, and their disease or condition may improve.
In addition, participants receive free laboratory and medical
testing. More often than not, the study medication is in
development because it works differently than other drugs on
the market, and therefore, it may present an alternative
course of treatment for the patient. Second, part icipation
in a clinical trial helps manufacturers make informed
decisions about whether to pursue getting a particular drug
approved by the Food & Drug Administration (FDA). Finally,
data from one patient (who completes the entire study) can be
an important part of a drug development program. In the best
case scenarios, these data can help get an exciting new drug
approved by the FDA, and ultimately, continue the industry's
efforts in developing medications that are safer, more
effective, and work faster than any before them.
How are a participant's rights and safety protected?
The FDA is the governing agency that develops the policies and
guidelines for all medical research, regardless of
manufacturer, study phase, or drug type. There are also
independent Institutional Review Boards (IRB) that review and
approve all study-related documents, such as protocols,
Informed Consent forms, physician credentials and eligibility,
and patient recruitment materials, such as print
advertisements and public service announcements.
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How Are Clinical Studies
of Mental Disorders Designed?
Clinical researchers call the standard
scientific approach for trying out treatments a
double-blind, randomized, controlled clinical trial.
Understanding this term, and knowing how and why this
approach is used, should help you to decide whether to
become a research volunteer.
An important part of scientific research
is comparison. Clinical research often will compare an
investigational treatment to one that is used frequently
and thus has familiar, or predictable, effects. To make
the comparison useful, the investigator must try both
methods on similar groups of subjects.
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