Database of adverse events occurring in clinical studies--useful and necessary?
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.
Hopf
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Chamber of Physicians Nordrhein, Tersteegenstr. 31, 40474 Düsseldorf, Germany.
Wermuth
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