Post marketing surveillance studies provide an opportunity to go beyond the pre-registration studies.
They can be designed to focus on questions raised during Phase II/III trials, or to answer questions relating to the effectiveness of the drug in its intended setting. Programs can be designed to study the safety profile of the drug in the real world, or in sensitive populations (children, elderly, immunosupressed, etc.) they can be designed to understand and/or influence prescriber and/or patient behaviour (ie. Compliance, disease awareness, why physicians prescribe certain brands etc.)
Post marketing surveillance studies improve physician confidence in using a newly launched product. Sponsors can benefit from the knowledge gained from a post marketing surveillance program and share that information across an organization to focus strategic plans.