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18. Clinical Trials

It takes about 13 years to develop a new anti-cancer drug, including 3 phases of clinical trials.

 

  • Step in Drug Development
  • Discovery and Animal
    Testing
  • Phase 1 Trial

  • Phase 2 Trial

  • Phase 3 Trial

  • FDA Approval
  • Timeframe
  • 4 yrs.

  • 2 yrs.

  • 2 yrs.

  • 4 yrs.

  • 1 yr.
  • # of Patients in Trial
  • n/a

  • 15-30

  • about 100

  • 1,000

  • n/a
  • Objective
  • Prove drug has anti-cancer properties and is
    not deadly.
  • Find safe dosage and confirm anti-cancer effect
    in humans.
  • Test drug effectiveness against specific form of
    cancer.
  • Compare new drug benefits to best then
    existing standard of care.
  • Validates claim to be made by the manufacturer
    about the drug’s benefits.

 

3%
Only 3% of American adults with cancer (in recent years) have signed up for clinical trials -- so many more trials are taking place overseas.
50%
About 50% of American children with cancer are willing to sign up for clinical trials.
1 in 1,000
The chances of a new anti-cancer drug making it from the lab to phase 1 trials.