ABSTRACT
Collection and submission of safety data in different phases of clinical trials are required by regulatory agencies for drug approval and postmarketing safety evaluation. In addition, beginning in 1968, the FDA established the Adverse Event Reporting System database to collect adverse event information associated with drugs from patients, health care professionals, and other sources through a spontaneous reporting system, and these data are available online through the Freedom of Information Act. Pharmacovigilance is the pharmacological science concerning data collection, monitoring, and detection of adverse reactions of medical products after they have been licensed for use in a country. Section 7.1 gives an overview of the large variety of safety databases, ranging from preclinical data to adverse event reporting systems for drugs and vaccines and health insurance claims databases. Section 7.2 discusses statistical issues in the analysis of spontaneous adverse event report databases and Sections 7.3-7.7 describe statistical methods to address them, and Section 7.8 gives an overview of pharmacoepidemiologic approaches to the analysis of these data. Section 7.9 describes the actual experience of pre-and post-marketing studies with the combination vaccine MMRV, about which Chapter 5 has described clinical safety data when it is used in combination with PedvaxH1Br. Supplements and problems are given in Section 7.10.
