Phase 4 Trial

Audio

Testing in humans that occurs after a drug (or other treatment) has already been approved by the Food and Drug Administration (FDA) and is being marketed for sale. Phase 4 trials are conducted to determine long-term safety and effectiveness and to identify adverse effects that may not have been apparent in prior trials. Phase 4 trials usually include thousands of participants.

Image(s): (Click to enlarge)

Print

Download Glossary