治験薬有害事象に関する標準的情報項目の検討

概要

論文の詳細を見る
The new Good Clinical Practice (new GCP) guidelines which conform to the international standard based on ethics and science (ICH-GCP) were applied to clinical drug research in Japan in April 1 997. However some problems still exist regarding clinical drug research based on the new GCP guidelines. One of the maior problems is the management of massive information regarding adverse events supplied from sponsors (drug company) in various styles. To solve this problem, we tried to make a database of the adverse events supplied by the manufacturers to determine the essential headings of information regarding adverse events, the questionnaire survey was performed on both doctors (n=20) and manufacturers (n = 25) . Based on the results of the survey, 17 standard information heads (including concomitant drugs, severity, relation of cause and effect, etc.) were determined. In the future the information on the ad-verse events consisting of 17 standard heading in the electronic medium (ex. floppy disk) should thus be supplied by sponsors to use in all hospitals which take an active role in the clinical drug research.
日本医療薬学会の論文
1999-04-10