臨床試験において収集される有害事象情報の実態調査

フォーマット:

論文

責任表示:

吉冨, 克則 ; 古川, 裕之 ; 宮本, 謙一

言語:

日本語

出版情報:

日本臨床薬理学会 = The Japanese Society of Clinical Pharmacology and Therapeutics, 2008-05-01

著者名:

• 吉冨, 克則
• 古川, 裕之
• 宮本, 謙一

掲載情報:

臨床薬理 = Japanese journal of clinical pharmacology

ISSN:

0388-1601      

巻:

39

通号:

3

開始ページ:

99

終了ページ:

104

バージョン:

publisher

概要:

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. 続きを見る

URL:

http://hdl.handle.net/2297/18242