{"created":"2023-05-15T14:40:45.660303+00:00","id":55903,"links":{},"metadata":{"_buckets":{"deposit":"6fb2ebed-9a67-4d94-abc8-c5e5baa20479"},"_deposit":{"created_by":1,"id":"55903","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"55903"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00055903","sets":["7"]},"author_link":["572034","572035","572036"],"item_10004_biblio_info_7":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2014-01","bibliographicIssueDateType":"Issued"},"bibliographicVolumeNumber":"9","bibliographic_titles":[{"bibliographic_title":"PLoS ONE (Online only:URL:http://www.plosone.org)"}]}]},"item_10004_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"Introduction: International norms and ethical standards have suggested that compensation for research-related injury\nshould be provided to injured research volunteers. However, statistical data of incidence of compensation claims and the\nrate of awarding them have been rarely reported.\nMethod: Questionnaire surveys were sent to pharmaceutical companies and medical institutions, focusing on industryinitiated\nclinical trials aiming at new drug applications (NDAs) on patient volunteers in Japan.\nResults: With the answers from pharmaceutical companies, the incidence of compensation was 0.8%, including 0.06% of\nmonetary compensation. Of the cases of compensation claims, 99% were awarded. In turn, with the answers from medical\ninstitutions, the incidence of compensation was 0.6%, including 0.4% of serious but not death cases, and 0.04% of death\ncases. Furthermore, most claims for compensation were initiated by medical institutions, rather than by the patients. On the\nother hand, with the answers from clinical trial volunteers, 3% of respondents received compensations. These compensated\ncases were 25% of the injuries which cannot be ruled out from the scope of compensation.\nConclusion: Our study results demonstrated that Japanese pharmaceutical companies have provided a high rate of\ncompensation for clinical trial-related injuries despite the possibility of overestimation. In the era of global clinical\ndevelopment, our study indicates the importance of further surveys to find each country’s compensation policy by\ndetermining how it is being implemented based on a survey of the actual status of compensation coming from statistical data.","subitem_description_type":"Abstract"}]},"item_10004_source_id_9":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"1932-6203","subitem_source_identifier_type":"ISSN"}]},"item_access_right":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"metadata only access","subitem_access_right_uri":"http://purl.org/coar/access_right/c_14cb"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"栗原, 千絵子"}],"nameIdentifiers":[{"nameIdentifier":"572034","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"et.al"}],"nameIdentifiers":[{"nameIdentifier":"572035","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"栗原 千絵子","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"572036","nameIdentifierScheme":"WEKO"}]}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"eng"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"High Rate of Awarding Compensation for Claims of Injuries Related to Clinical Trials by Pharmaceutical Companies in Japan: A Questionnaire Survey","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"High Rate of Awarding Compensation for Claims of Injuries Related to Clinical Trials by Pharmaceutical Companies in Japan: A Questionnaire Survey"}]},"item_type_id":"10004","owner":"1","path":["7"],"pubdate":{"attribute_name":"公開日","attribute_value":"2014-01-15"},"publish_date":"2014-01-15","publish_status":"0","recid":"55903","relation_version_is_last":true,"title":["High Rate of Awarding Compensation for Claims of Injuries Related to Clinical Trials by Pharmaceutical Companies in Japan: A Questionnaire Survey"],"weko_creator_id":"1","weko_shared_id":-1},"updated":"2023-05-15T22:44:03.343153+00:00"}