What is a Clinical
Trial? Why are they done?
- Clinical research assists
in gathering evidence to substantiate off label use
- 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 patientsí rights are fully
protected and they are not exposed to any unnecessary
same ethical and legal codes that govern medical
practice also apply to clinical
research is federally regulated with built in
safeguards to protect the participants
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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