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Sydney Adventist Hospital
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Clinical Specialties - Cancer

Clinical Trial Phases

There are four phases of Clinical Trials.

Phase 1

  • First studies that involve humans
  • Test how the drug should be given and if it is safe
  • Small numbers of healthy volunteers or terminally ill people
  • Duration – days to weeks

Phase 2

  • Look at safety and efficacy
  • Seek to find the best dose – maximum benefit and minimum side effects
  • More people involved, usually 50 – 200
  • Duration – months to years

Phase 3

  • Confirm safety and efficacy
  • Often comparison with 'standard of care' drug
  • Larger numbers of people, 100 – 1000’s
  • Duration – months to years
  • Provide the data for government approval of drugs

Phase 4

  • Long term safety monitoring and information gathering
  • Post marketing approval

At San Clinical Trials Unit we concentrate on Phase 2, 3 and 4 clinical trials.

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Sydney Adventist Hospital Clinical Specialties and Services