Clinical Trial Phases

Question 1

Phase 2

Answer 1

Safety and efficacy, used in intended population, 100-300 patients, 1-2 years

Question 2

Phase 3

Answer 2

Safety, efficacy, and effectiveness at the dose and schedule that you are seeking approval, subjects with indications the drug is seeking, 100-thousands of patients, 2-3 years

Question 3

Phase 4

Answer 3

New indications, QOL, surveillance studies, hundreds to thousands, 1-5 years

Question 4

Supplemental new drug application

Answer 4

Labeling changes, new dose, new strength, new manufacturing process

Question 5

Phase 1

Answer 5

Safety profile and dosing range, PK/PD, open label, 1 center, small people (20-80ppl), length of time (6-12 months). Healthy volunteers usually