{"created":"2023-05-15T14:40:42.359940+00:00","id":55835,"links":{},"metadata":{"_buckets":{"deposit":"0bda4e8d-a555-47dd-aac2-c434ff6ef437"},"_deposit":{"created_by":1,"id":"55835","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"55835"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00055835","sets":["7"]},"author_link":["571333","571332","571349","571366","571336","571328","571339","571354","571346","571331","571335","571334","571361","571348","571365","571350","571357","571343","571364","571347","571355","571360","571362","571340","571351","571337","571342","571338","571345","571352","571353","571341","571344","571359","571363","571358","571330","571356","571329"],"item_10004_biblio_info_7":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2013","bibliographicIssueDateType":"Issued"},"bibliographicPageEnd":"18","bibliographicPageStart":"1","bibliographic_titles":[{"bibliographic_title":"厚生労働科学研究費補助金（医薬品・医療機器等レギュラトリーサイエンス総合研究事業）「治験に係る健康被害発生時の被験者保護に関する研究」報告書"}]}]},"item_10004_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"　医師主導治験は、製薬企業が治験に着手しない場合であっても、医療機関・医師自らが治\n験届を提出してデータを取得することにより、医薬品の承認に活用できるよう平成15年の改\n正GCPにより制度整備された。その促進を目的にこれまで運用の改善が図られてきたが、前\n年度研究（厚生労働科学研究費補助金：医薬品・医療機器等レギュラトリーサイエンス総合\n研究事業：医師主導治験の運用に関する研究）において依然いくつかの課題が存在すること\nが明らかとなった。また、我が国で実施される医師主導治験は、ほとんどがII/III相治験であ\nり、期待される早期相の医師主導治験は極めて乏しく、国内のアカデミアから創出されたシ\nーズさえも海外でI相試験が実施される現状であった。\n本研究では、被験者の安全性を保護し、データの信頼性を確保しながら、医師主導治験等\nを我が国で活性化させることを目的とし、1)医師主導治験と先進医療の使い分けに焦点を当\nてた医師主導治験の制度に関する研究、2) 日本及び世界の臨床試験の実施状況、及び承認\n申請での活用状況に関する調査研究、3) 治験関連文書における電磁的記録の活用に関する\n研究、4) リスクに基づくSDV 等のあり方に関する調査研究、5) 治験における臨床検査等\n制度管理のあり方に関する研究、6) 共同IRB のあり方に関する研究、7) ヒト初回投与試験\nの説明、同意取得に関する研究、を実施した。研究結果に基づき、課題を解決するために\nGCP 運用上可能な対策を提案するとともに具体例を提示した。\n本研究成果は、医師主導治験のみならず企業型治験の効率化にも大きく資するものである。\n今後、我が国における医師主導治験等の環境がさらに整備され、その実施数が増加すること\nによって、アカデミア発のシーズの国外流出の抑制、企業への円滑なデータ移行が促進され、\n国際競争力を持つ医薬品産業が我が国に保持されること、最新かつ質の高い医療を患者に提\n供する体制が確保されることが期待される。","subitem_description_type":"Abstract"}]},"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":"渡邉, 裕司"}],"nameIdentifiers":[{"nameIdentifier":"571328","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"景山, 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