FA2019 p256 "SWIM"

• 1 - small, healthy group or volunteers w/ disease- Is it S afe
• 2 - moderate-sized group w/ disease - Does it W ork
• 3 - large group w/ disease/RCT - Is it an I mprovement compared to currently available treatment
• 4 - Surveillance after approval - Can it stay on the M arket?

Phase 1- small # of healthy people. Is the drug safe? Phase 2- smell # with disease. Does it work? Phase 3- large #, some with new drug, some with old. Is is good or better? Phase 4- Postmarket watch. Can it stay?