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What is a Clinical
Trial? Why are they done?
- Clinical research assists
in gathering evidence to substantiate off label use
and to
gain
FDA approval.
- These drugs may
have been used "off label" in practice for years
and deemed effective by treating
professionals, however clinical trials have never
been conducted specific to the diagnosis.
- All clinical trials are
overseen by an IRB (Independent Review Board) and FDA (Food
and Drug Administration).
- The IRB ensures
that the patients’ rights are fully
protected and they are not exposed to any unnecessary
risks.
- The
same ethical and legal codes that govern medical
practice also apply to clinical
research.
- Clinical
research is federally regulated with built in
safeguards to protect the participants
involved.
- Before
a pharmaceutical company can initiate a clinical
trial, it must conduct extensive prior research
and have the study protocol approved
by the FDA.
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