Phases

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions.

  • Phase I - researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
  • Phase II - the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
  • Phase III - the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.
  • Phase IV - post marketing studies delineate additional information including the drug or treatment’s risks, benefits, and optimal use.