Promotie J.H.G. (Joep) Scholl

Signal detection in pharmacovigilance: time for a new era?

Statistical methods can be helpful in detecting adverse drug reactions. When a drug enters the market, not all adverse drug reactions are known. An important source of information are reports of adverse drug reactions from healthcare professional and patients analyzed by Pharmacovigilance Centre Lareb. In his thesis, Joep Scholl describes several statistical methods that can be used to detect still unknown adverse drug reactions. To do this, he developed a model that is used to prioritize possible safety signals. This allows the most promising signals to be analyzed first, resulting in a more efficient way of working. Additionally, factors possibly influencing statistical analyses were investigated. This proved to be the case in low-threshold reporting, where a high number of these reports disrupt the analyses. Finally, the time from the start of a drug until the start of an adverse drug reaction was investigated as a parameter to detect new adverse drug reactions. The research described in this thesis contributes to a better and more efficient analysis of adverse drug reactions and ultimately to a safer use of medicines.

Promotores Prof.dr. E.P. van Puienbroek en Prof.dr. E. Hak