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臨床試験において収集される有害事象情報の実態調査
http://hdl.handle.net/2297/18242
http://hdl.handle.net/2297/18242e1468dc6-51fd-4572-a405-7767cc80cb31
| 名前 / ファイル | ライセンス | アクション |
|---|---|---|
PH-PR-MIYAMOTO-K-99.pdf (237.7 kB)
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| Item type | 学術雑誌論文 / Journal Article(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2017-10-04 | |||||
| タイトル | ||||||
| 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 | |||||
| タイトル | ||||||
| タイトル | Survey of the information of adverse events in clinical trials | |||||
| 言語 | en | |||||
| 言語 | ||||||
| 言語 | jpn | |||||
| 資源タイプ | ||||||
| 資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
| 資源タイプ | journal article | |||||
| 著者 |
吉冨, 克則
× 吉冨, 克則× 古川, 裕之× 宮本, 謙一 |
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| 書誌情報 |
臨床薬理 = Japanese journal of clinical pharmacology 巻 39, 号 3, p. 99-104, 発行日 2008-05-01 |
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| ISSN | ||||||
| 収録物識別子タイプ | ISSN | |||||
| 収録物識別子 | 0388-1601 | |||||
| NCID | ||||||
| 収録物識別子タイプ | NCID | |||||
| 収録物識別子 | AN0025404X | |||||
| DOI | ||||||
| 関連タイプ | isIdenticalTo | |||||
| 識別子タイプ | DOI | |||||
| 関連識別子 | 10.3999/jscpt.39.99 | |||||
| 出版者 | ||||||
| 出版者 | 日本臨床薬理学会 = The Japanese Society of Clinical Pharmacology and Therapeutics | |||||
| 抄録 | ||||||
| 内容記述タイプ | Abstract | |||||
| 内容記述 | 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. | |||||
| 権利 | ||||||
| 権利情報 | Copyright (c) 2009 日本臨床薬理学会 | |||||
| 著者版フラグ | ||||||
| 出版タイプ | VoR | |||||
| 出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||
| 関連URI | ||||||
| 識別子タイプ | URI | |||||
| 関連識別子 | http://www.jscpt.jp/ | |||||
| 関連URI | ||||||
| 識別子タイプ | URI | |||||
| 関連識別子 | http://www.jstage.jst.go.jp/article/jscpt/39/3/39_99/_article/-char/ja | |||||
