Database of adverse events occurring in clinical studies--useful and necessary?

Abstract

Due to an amendment of the German Drug Act ethic committees must be informed of all serious or unexpected adverse events occurring during a clinical study. This means that ethic committees may have to reevaluate their recommendations. A database is presented in order to help an ethic committee in decision making. Preliminary results indicate that this database may be helpful in future and-additionally-may be the beginning of pharmacovigilance.