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phase IV trial
Pronunciation
Definition 1
A type of clinical trial that studies the side effects of a treatment after it has been approved and is being marketed. These trials include thousands of people and look for side effects that were not seen in earlier trials. Also called post-marketing surveillance trial. (NCI Dictionary)
Definition 2
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. (NCI Thesaurus)
Definition 3
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. (NCI Dictionary)
Definition 4
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) (NCI Thesaurus/CDISC)
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