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著作: Watanabe Miho/Tajima Soichiro/[片島 るみ]/Miyamoto Toshiko/Yamagami Makiko/[水口 和生]/[楊河 宏章]/Serious adverse events and compensation in registration trials: a review of data from a Japanese university hospital./[BMC Research Notes]

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EID
284656
EOID
762943
Map
0
LastModified
2015年1月11日(日) 20:23:21
Operator
大家 隆弘
Avail
TRUE
Censor
0
Owner
片島 るみ
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種別 必須 学術論文(審査論文)
言語 必須 英語
招待 推奨
審査 推奨
カテゴリ 推奨
共著種別 推奨
学究種別 推奨
組織 推奨
著者 必須
  1. (英) Watanabe Miho
    役割 任意
    貢献度 任意
    学籍番号 推奨
  2. (英) Tajima Soichiro
    役割 任意
    貢献度 任意
    学籍番号 推奨
  3. 片島 るみ
    役割 任意
    貢献度 任意
    学籍番号 推奨
  4. (英) Miyamoto Toshiko
    役割 任意
    貢献度 任意
    学籍番号 推奨
  5. (英) Yamagami Makiko
    役割 任意
    貢献度 任意
    学籍番号 推奨
  6. 水口 和生
    役割 任意
    貢献度 任意
    学籍番号 推奨
  7. 楊河 宏章([徳島大学.病院.中央診療施設等.総合臨床研究センター])
    役割 任意
    貢献度 任意
    学籍番号 推奨
題名 必須

(英) Serious adverse events and compensation in registration trials: a review of data from a Japanese university hospital.

副題 任意
要約 任意

(英) Clinical trials leading to regulatory approval, or registration trials, play a central role in the development of drugs and medical devices. The contribution of support staff, such as the clinical research coordinator (CRC) and administrative officers, in registration trials is now widely recognized. Attending to serious adverse events is an important duty of the CRC and investigators alike, and managing these complications and compensation constitutes a key responsibility. We retrospectively examined the frequency of serious adverse events and compensation events reported from 2007 through 2011 at Tokushima University Hospital, an academic hospital in rural Japan. We present herein the results of our analysis. Over the five-year period, 284 subjects participating in 106 registration trials experienced a total of 43 serious adverse events, and eight compensation events were documented. Among the serious adverse events, 35 (81.4%) were considered not related to the investigational drug, and 17 (39.5%) resulted in withdrawal of the study drug. Patients with malignant diseases experienced serious adverse events significantly more frequently compared to those with non-malignant diseases (28.3% versus 8.2%, respectively; P < 0.01). The CRC should be vigilant for serious adverse events in oncology clinical trials due to the generally higher frequency of these complications in subjects with malignancy. However, on an individual basis, the CRC may be seldom involved in the process for compensating serious adverse events. Therefore, the CRC's ability to share such experiences may serve as an opportunity for educating clinical trial support staff at the study site as well as those at other sites. However, further study is warranted to determine the role of the clinical trial support staff in optimizing methods for managing adverse events requiring compensation in registration trials.

キーワード 推奨
発行所 推奨
誌名 必須 BMC Research Notes([BioMed Central Ltd.])
(eISSN: 1756-0500)
ISSN 任意 1756-0500
ISSN: 1756-0500 (eISSN: 1756-0500)
Title: BMC research notes
Title(ISO): BMC Res Notes
Publisher: BioMed Central
 (NLM Catalog  (Scopus  (CrossRef (Scopus information is found. [need login])
必須 7
必須
必須 245 245
都市 任意
年月日 必須 2014年 4月 17日
URL 任意
DOI 任意 10.1186/1756-0500-7-245    (→Scopusで検索)
PMID 任意 24742228    (→Scopusで検索)
NAID 任意
WOS 任意
Scopus 任意
評価値 任意
被引用数 任意
指導教員 推奨
備考 任意
  1. (英) Article.ELocationID: 10.1186/1756-0500-7-245

  2. (英) Article.PublicationTypeList.PublicationType: Journal Article

  3. (英) OtherID: PMC3996165