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What is a Clinical Trial?  Why are they done?

  • A clinical trial is a carefully designed study that involves individuals who volunteer to receive investigational treatments under the close supervision of a physician and research professionals.
  • 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 patientsí 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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