When Should One Perform Pharmacoepidemiologic Studies?

This chapter reviews when pharmacoepidemiology studies should be performed. It begins with a discussion of the various reasons why one might perform pharmacoepidemiologic studies. The decision to conduct a pharmacoepidemiology study can be viewed as similar to the regulatory decision about whether to approve a drug for marketing or the clinical decision about whether to prescribe a drug. Perhaps the most obvious and compelling reason to perform a postmarketing pharmacoepidemiologic study is regulatory: a plan for a postmarketing pharmacoepidemiologic study is required before the drug will be approved for marketing. A pharmacoepidemiologic study can be useful to improve product name recognition. Postmarketing surveillance studies can theoretically be useful as legal prophylaxis, in anticipation of eventually having to defend against product liability suits. The major reason for most pharmacoepidemiologic studies is hypothesis testing. Hypothesis generating studies are intended to screen for unknown and unsuspected drug effects.