What are the different stages of clinical trials?

  • Phase 1 is the first time a medicine is tried on human beings.  The point of a Phase 1 study is to see if the drug is safe.
  • Phase 2 is when the medicine is safe, and now researchers want to start learning about how it works.  They also want to start finding out how much of the medicine is needed (the dose).
  • Phase 3 is when the medicine is safe and they know that it works.  Now the researchers want to compare this new medicine to other medicines and see which one is the best.
  • Phase 4 is when the drug has been approved by the FDA, but researchers want to keep monitoring to get extra information.