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.