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Database of adverse events occurring in clinical studies—useful and necessary?
Author(s) -
Hopf G.,
Wermuth M.
Publication year - 1998
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/(sici)1099-1557(199808)7:1+<s70::aid-pds350>3.0.co;2-m
Subject(s) - medicine , pharmacoepidemiology , database , adverse effect , medical emergency , pharmacology , computer science , medical prescription
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. © 1998 John Wiley & Sons, Ltd.