Analyses of Spontaneous Adverse Drug Reaction Databases Using Descriptive and Inferential Statistics

Abstract

The presented cumulative dissertation summarizes four scientific research papers of analyses assessing data of the adverse drug reaction (ADR) database of the Federal Institute for Drugs and Medical Devices (BfArM) and the European ADR database (EudraVigilance) of the European Medicines Agency (EMA). The objective was to analyse all ADR reports contained in BfArM’s ADR database descriptively for the first time and subsequently with regard to three relevant pharmacovigilance questions. Therefore, research strategies for the identification of the cases depending on the research question were established and different statistical methods were used. Two of the known limitations of analysis performed in ADR databases are the lack of matching control groups and exact exposure data. To overcome these issues, we generated control groups within the ADR database and used external data sources to set the number of ADR reports in relation to the number of inhabitants and assumed drug-exposed inhabitants.