{"created":"2021-03-01T06:12:26.388347+00:00","id":5857,"links":{},"metadata":{"_buckets":{"deposit":"73ab46e5-ef84-4118-b51a-dbbe57670ed4"},"_deposit":{"created_by":17,"id":"5857","owners":[17],"pid":{"revision_id":0,"type":"depid","value":"5857"},"status":"published"},"_oai":{"id":"oai:nagoya.repo.nii.ac.jp:00005857","sets":["499:508:509:729"]},"author_link":["15590","15591"],"item_1615768549627":{"attribute_name":"出版タイプ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_9_biblio_info_6":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2007-01","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"1-2","bibliographicPageEnd":"16","bibliographicPageStart":"9","bibliographicVolumeNumber":"69","bibliographic_titles":[{"bibliographic_title":"Nagoya Journal of Medical Science","bibliographic_titleLang":"en"}]}]},"item_9_description_4":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"Several complicated steps are should be necessary to bring bioscientific products successfully to market. Products generated on the bench first have to be called screened for safety in a Phase I clinical trial. This step is called translational research, indicating that the material must be proven safe not only for experimental animals, but also for human subjects. Once the Phase I study is completed, Phase II determines the safety of the bioscientific products on humans, establishing both its maximum tolerated dose and recommended dose. In a Phase II study, the material should be tested for its efficacy against certain diseases. Once it is found to be effective, a comparison between the current actual standard therapy and the new therapy using the newly developed material will be implemented in a large or against scale randomized trial, after which a final decision must be made for its approval as a new drug. The authors have illustrated the steps of: a Phase I translational research by showing the data of a monoclonal antibody A33; a Phase II trial with several combination chemotherapies of chemotherapeutic agents; a Phase III clinical trial through a comparison of antihypertension agents to show the evolutionary process from translational research to a large randomized trial based on their own experience.","subitem_description_language":"en","subitem_description_type":"Abstract"}]},"item_9_identifier_60":{"attribute_name":"URI","attribute_value_mlt":[{"subitem_identifier_type":"HDL","subitem_identifier_uri":"http://hdl.handle.net/2237/7473"}]},"item_9_identifier_registration":{"attribute_name":"ID登録","attribute_value_mlt":[{"subitem_identifier_reg_text":"10.18999/nagjms.69.1-2.9","subitem_identifier_reg_type":"JaLC"}]},"item_9_publisher_32":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"Nagoya University School of Medicine","subitem_publisher_language":"en"}]},"item_9_select_15":{"attribute_name":"著者版フラグ","attribute_value_mlt":[{"subitem_select_item":"publisher"}]},"item_9_source_id_61":{"attribute_name":"ISSN（Online）","attribute_value_mlt":[{"subitem_source_identifier":"2186-3326","subitem_source_identifier_type":"EISSN"}]},"item_9_source_id_7":{"attribute_name":"ISSN（print）","attribute_value_mlt":[{"subitem_source_identifier":"0027-7622","subitem_source_identifier_type":"PISSN"}]},"item_9_text_14":{"attribute_name":"フォーマット","attribute_value_mlt":[{"subitem_text_value":"application/pdf"}]},"item_access_right":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"open access","subitem_access_right_uri":"http://purl.org/coar/access_right/c_abf2"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"Sakamoto, Junichi","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"15590","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"Morita, Satoshi","creatorNameLang":"en"}],"nameIdentifiers":[{"nameIdentifier":"15591","nameIdentifierScheme":"WEKO"}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_date","date":[{"dateType":"Available","dateValue":"2018-02-19"}],"displaytype":"detail","filename":"p009-016.pdf","filesize":[{"value":"181.8 kB"}],"format":"application/pdf","licensetype":"license_note","mimetype":"application/pdf","url":{"label":"p009-016.pdf","objectType":"fulltext","url":"https://nagoya.repo.nii.ac.jp/record/5857/files/p009-016.pdf"},"version_id":"d40d0312-8ea8-489e-ae82-7dbf2e6ba3a1"}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"Translational research","subitem_subject_scheme":"Other"},{"subitem_subject":"Clinical trials","subitem_subject_scheme":"Other"},{"subitem_subject":"Large-scale randomized clinical trial","subitem_subject_scheme":"Other"}]},"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":"departmental bulletin paper","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"From Translational Research to a Large Randomized Clinical Trial : A Long and Streanuous Way from Bench to Bedside","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"From Translational Research to a Large Randomized Clinical Trial : A Long and Streanuous Way from Bench to Bedside","subitem_title_language":"en"}]},"item_type_id":"9","owner":"17","path":["729"],"pubdate":{"attribute_name":"PubDate","attribute_value":"2007-03-19"},"publish_date":"2007-03-19","publish_status":"0","recid":"5857","relation_version_is_last":true,"title":["From Translational Research to a Large Randomized Clinical Trial : A Long and Streanuous Way from Bench to Bedside"],"weko_creator_id":"17","weko_shared_id":-1},"updated":"2023-11-16T06:33:30.470711+00:00"}