{"created":"2023-05-15T14:40:39.979172+00:00","id":55793,"links":{},"metadata":{"_buckets":{"deposit":"300b336e-537a-45aa-a56b-dfcb641d1a81"},"_deposit":{"created_by":1,"id":"55793","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"55793"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00055793","sets":["7"]},"author_link":["570888","570882","570880","570873","570876","570879","570881","570883","570884","570885","570874","570877","570878","570889","570890","570887","570875","570872","570886","570871"],"item_10004_biblio_info_7":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2012","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"1","bibliographicPageEnd":"18","bibliographicPageStart":"5","bibliographicVolumeNumber":"40","bibliographic_titles":[{"bibliographic_title":"臨床評価"}]}]},"item_10004_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"　平成15（2003）年の改正薬事法（「薬事法及び採血及び供血あっせん業取締法の一部を改正する法律」（平成14 年法律第96 号））の施行により，医師が主導する治験実施が可能となった．しかし，制度導入以降，その件数は期待された伸びを示さず，現状においても年間10 件程度の実施にとどまっている．企業治験に比し，担当医師や治験事務局の業務が複雑かつ大量であることも，医師主導治験の実施に踏み切ることを躊躇させる理由となっている．さらに，医師主導治験の現状を把握するためには，薬事法上に定義される（狭義の医師主導治験のみに着目した分析や提案だけでは不十分であり，世界の中で日本の臨床試験・臨床研究が置かれた状況や日本及び世界のグローバル企業の医薬品等のビジネスの現状を俯瞰する必要がある．\n一方，医療機関では治験ではなく自主臨床研究として未承認薬を使用した臨床試験が実施されているが，その臨床データは新薬承認のために有効に利用されない．今後，医師主導治験から革新的医薬品がつぎつぎと創出されるように，あるいは，医師が実施した臨床試験データを企業が引き継ぎ治験データとして有効に活用できるようにするための制度構築が求められる．\nわれわれは，平成23 年度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\nエンス総合研究事業として「医師主導治験の運用に関する研究」を実施した．医師主導治験の制度，医師主導治験に対する責任医師の対応，製薬企業側からみた医師主導治験のあり方，国内外の臨床試験の実施状況，さらに，早期臨床開発に対応する医師主導治験のあり方など，多面的な検討を加えたが，本論文は，これら研究成果に基づくものである","subitem_description_type":"Abstract"}]},"item_10004_source_id_9":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"0300-3051","subitem_source_identifier_type":"ISSN"}]},"item_access_right":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"metadata only 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