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High Rate of Awarding Compensation for Claims of Injuries Related to Clinical Trials by Pharmaceutical Companies in Japan: A Questionnaire Survey
https://repo.qst.go.jp/records/55903
https://repo.qst.go.jp/records/5590368402599-0c5b-4cbc-8334-73dbc7f2a650
Item type | 一般雑誌記事 / Article(1) | |||||
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公開日 | 2014-01-15 | |||||
タイトル | ||||||
タイトル | High Rate of Awarding Compensation for Claims of Injuries Related to Clinical Trials by Pharmaceutical Companies in Japan: A Questionnaire Survey | |||||
言語 | ||||||
言語 | eng | |||||
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 | article | |||||
アクセス権 | ||||||
アクセス権 | metadata only access | |||||
アクセス権URI | http://purl.org/coar/access_right/c_14cb | |||||
著者 |
栗原, 千絵子
× 栗原, 千絵子× et.al× 栗原 千絵子 |
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抄録 | ||||||
内容記述タイプ | Abstract | |||||
内容記述 | Introduction: International norms and ethical standards have suggested that compensation for research-related injury should be provided to injured research volunteers. However, statistical data of incidence of compensation claims and the rate of awarding them have been rarely reported. Method: Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industryinitiated clinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan. Results: With the answers from pharmaceutical companies, the incidence of compensation was 0.8%, including 0.06% of monetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medical institutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of death cases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On the other hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensated cases were 25% of the injuries which cannot be ruled out from the scope of compensation. Conclusion: Our study results demonstrated that Japanese pharmaceutical companies have provided a high rate of compensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinical development, our study indicates the importance of further surveys to find each country’s compensation policy by determining how it is being implemented based on a survey of the actual status of compensation coming from statistical data. |
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書誌情報 |
PLoS ONE (Online only:URL:http://www.plosone.org) 巻 9, 発行日 2014-01 |
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ISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 1932-6203 |