Phases of Clinical Trials

Start here researchers conduct discovery and experiments to gather information on: 1111111111 researchers discover new drugs through: development best way to give the drug new insights potential benefits technology side molecular the best effects existing treatments tests dosage the many phases of pre-clinical cresearch FDA reviews clinical trials developer's new drug application (NDA) reports of problems (can take years) in vitro in vivo isolate cell/ tissue outside living organism test drug on living organism clinical research Phase 1 Phase 4 patients: 20-100 Phase 2 Phase 3 patients: several thousand study length: varies study length: several months patients: several hundred study length: months-2 years purpose: efficacy, side effects patients: 300-3,000 purpose: safety, dosage study length: 1-4 years purpose: safety, efficacy purpose: monitor adverse reactions