3105.0: Monday, November 13, 2000 - 2:30 PM

Abstract #7115

Post-marketing surveillance: Objectives and methods

Sean Hennessy, PharmD, School of Medicine, University of Pennsylvania, 803 Blockley Hall, Philadelphia, PA 19104-6021, 215-898-9112, shenness@cceb.med.upenn.edu

Postmarketing surveillance refers to any means of gathering information about a product after it has been approved for public use. Postmarketing surveillance studies address assorted aspects of beneficial and detrimental drug effects, including the existence of particular causal effects, frequency of and risk factors for certain outcomes, economic consequences of therapy, and characterization of drug use in clinical practice. The primary scientific discipline engaged in postmarketing studies is epidemiology. The principal epidemiologic study designs used in postmarketing surveillance studies are randomized trials, cohort studies, and case-control studies. Regardless of their design, all studies involving human subjects should be conducted by qualified investigators according to a written protocol that has been approved by an institutional review board. Promotional activities conducted under the guise of postmarketing studies are unacceptable.

Learning Objectives: Overall, the symposium will provide the participants with the opportunity to become familiar with different strategies and methodologies for post-marketing surveillance programs

Keywords: Surveillance, Data Collection

Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.

The 128th Annual Meeting of APHA