Post approval studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [after FDA CDER handbook, ICH E8]

Phase 4. Postmarketing (Phase 4) studies to delineate additional information about the drug's risks, benefits, and optimal use that may be requested by regulatory authorities in conjunction with marketing approval. NOTE: These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. [After FDA CDER Handbook, ICH E8] (CDISC glossary)

After a treatment has been approved and is being marketed, it is studied in a phase IV trial to evaluate side effects that were not apparent in the phase III trial. Thousands of people are involved in a phase IV trial.

CDISC

CDISC-GLOSS

Phase_IV_Trial

Phase IV Trial

Research Activity

C0282462

C15603

A randomized, controlled trial that is designed to evaluate the long-term safety and efficacy of a drug for a given indication. Often they are designed to study side effects that may have become apparent after the phase III study was completed.

Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.

phase 4

Trial Phase 4

Phase IV Trial

Phase IV Clinical Trials

4

Phase IV Study

Phase 4 Study

PHASE IV TRIAL

Clinical Trials, Phase IV

phase IV trial

http://purl.obolibrary.org/obo/ncit.owl