Postmarketing Surveillance Studies: Practical Issues in Design and Management

Abstract

Postmarketing surveillance studies differ from preapproval clinical trials in many ways; one of which is the number of patients studied — thousands versus hundreds. As a result, the management of such a study puts great demands on a company's internal resources. In order to preserve these resources pharmaceutical companies often decide to have such studies conducted by contract research organizations. This article discusses one company's experience in the development and conduct of a postmarketing surveillance study using internal staff. The development of two project teams, one dedicated to study design and monitoring and the other to data processing, was the first critical step. Continuous cooperation and communication between the teams were required to ensure successful completion of the study. This article concludes that postmarketing surveillance studies can be initiated and conducted successfully using internal staff, however, issues such as investigator recruitment and case report form design proved to be crucial and should be thoroughly addressed in planning such studies.