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Clinical Trials

The Phases of a Clinical Trial

Understanding the Phases of Clinical Trials

Prescription drugs don’t just show up on pharmacy shelves one day. Each one is first subjected to thorough scientific testing during what are known as clinical trials.

Clinical trials are conducted in phases, each of which is designed to assess a treatment or drug’s safety as well as answer different questions researchers may have about a drug or treatment. Clinical trial phases range from phase 0 to phase 4.

[1] [2] [3] [4] [5] [6] [7] [8]

References

  • 1. U.S. Food and Drug Administration. The FDA’s drug review process: ensuring drugs are safe and effective. Accessed September 13, 2013.
  • 2. ClinicalTrials.gov. Glossary of common site terms. Accessed September 16, 2013.
  • 3. ClinicalTrials.gov. ClinicalTrial.gov protocol data element definitions (draft). Accessed September 16, 2013.
  • 4. U.S. Food and Drug Administration. Inside clinical trials: testing medical products in people. Accessed September 16, 2013.
  • 5. National Institutes of Health. The basics. Accessed September 13, 2013.
  • 6. Pfizer. What are clinical trials? Accessed September 13, 2013.
  • 7. NIH MedlinePlus. What are clinical trials? Accessed September 13, 2013.
  • 8. U.S. Food and Drug Administration. Questions and answers on FDA’s postmarketing safety of recently approved drugs and biologics. Accessed September 16, 2013.
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