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タイトル: 臨床試験において収集される有害事象情報の実態調査
その他のタイトル: Survey of the information of adverse events in clinical trials
著者: 吉冨, 克則
古川, 裕之
宮本, 謙一 link image
Yoshitomi, Katsunori
Furukawa, Hiroyuki
Miyamoto, Kenichi
発行日: 2008年 5月
出版社(者): 日本臨床薬理学会 = The Japanese Society of Clinical Pharmacology and Therapeutics
雑誌名: 臨床薬理 = Japanese journal of clinical pharmacology
ISSN: 0388-1601
巻: 39
号: 3
開始ページ: 99
終了ページ: 104
キーワード: Adverse event
Case report form
Clinical trial
Outcome
Severity
抄録: Protocols and case report forms are different among clinical trials, however adverse events (AEs) occur in every trial and need to be assessed in the same way. Therefore, we conducted a survey to examine the actual condition of the information of AEs. We surveyed choices and criterions of items for AEs of 59 trials which were performed in Kanazawa University Hospital. As a result of the survey, it became clear that choices currently used for each item were varied and different in each trial. Criteria of severity and outcome were also varied ; there were even contradicting criteria among trials. There were also contradictory judgments of adverse drug reactions (ADRs), and the definition of "Probably not" expressed as an ADR differed. Moreover, in these trials, the criteria for "Probably not" was not markedly different. From these results, it was suggested that current the collection and assessment of the information of AEs were different in each trial and thereby assessments could also be different. Pharmaceutical companies, regulatory agenceis, and medical institutions should be in discussion to determine standardization of the expression of choices and criterions of AEs.
DOI: 10.3999/jscpt.39.99
URI: http://hdl.handle.net/2297/18242
関連URI: http://www.jscpt.jp/
http://www.jstage.jst.go.jp/article/jscpt/39/3/39_99/_article/-char/ja
資料種別: Journal Article
権利関係: Copyright (c) 2009 日本臨床薬理学会
版表示: publisher
出現コレクション:2.査読済論文(薬)

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