Updated: 2/11/2018

Clinical Trials

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Overview
  • Experimental study of medical treatment in humans
  • 2 or more treatments (or treatment and placebo) are compared
  • Highest quality if
    • Randomized
    • Controlled
    • Double-blinded
  • 4 phases
    • Phase I
      • Small number of healthy subjects
      • Determines safe dose range and side effects
    • Phase II
      • Small number of diseased patients
      • Refines dosage and safety profile
    • Phase III
      • Large number of diseased patients
      • Confirms effectiveness
      • Compare to standard of care
    • Phase IV
      • Post-marketing surveillance
      • Detects rare or long-term adverse effects
 

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