Guidelines for good pharmacoepidemiology practice (GPP)

Pharmacoepidemiologic studies provide valuable information about the health effects of healthcare products. The ISPE Guidelines for Good Pharmacoepidemiology Practice (GPP) are intended to assist investigators with issues pertaining to the planning, conduct, and interpretation of pharmacoepidemiologic research. This paper represents the fourth version and supersedes previous versions. While the overall structure and nature of the GPP has been preserved in the current revision, new sections have been added, and the text has been updated to reflect current practice. Pharmacoepidemiology is being used increasingly to evaluate health care systems, interventions, and healthrelated behaviors. Pharmacoepidemiology is the scientific backbone of therapeutic risk management— the process of assessing a product’s benefits and risks, and developing, implementing, and evaluating strategies to enhance the overall balance of such benefits and risks. Pharmacoepidemiology is also the scientific backbone of comparative effectiveness research (CER). These guidelines are intended to address these activities and other pharmacoepidemiologic studies. The GPP addresses the following areas: • protocol development, • responsibilities, personnel, facilities, resource commitment, and contractors, • study conduct, • communication, • adverse event reporting, and • archiving Goals