{"_buckets": {"deposit": "73ab46e5-ef84-4118-b51a-dbbe57670ed4"}, "_deposit": {"id": "5857", "owners": [], "pid": {"revision_id": 0, "type": "depid", "value": "5857"}, "status": "published"}, "_oai": {"id": "oai:nagoya.repo.nii.ac.jp:00005857"}, "item_9_biblio_info_6": {"attribute_name": "\u66f8\u8a8c\u60c5\u5831", "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"}]}]}, "item_9_description_4": {"attribute_name": "\u6284\u9332", "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_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\u767b\u9332", "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": "\u51fa\u7248\u8005", "attribute_value_mlt": [{"subitem_publisher": "Nagoya University School of Medicine"}]}, "item_9_select_15": {"attribute_name": "\u8457\u8005\u7248\u30d5\u30e9\u30b0", "attribute_value_mlt": [{"subitem_select_item": "publisher"}]}, "item_9_source_id_7": {"attribute_name": "ISSN\uff08print\uff09", "attribute_value_mlt": [{"subitem_source_identifier": "0027-7622", "subitem_source_identifier_type": "ISSN"}]}, "item_9_text_14": {"attribute_name": "\u30d5\u30a9\u30fc\u30de\u30c3\u30c8", "attribute_value_mlt": [{"subitem_text_value": "application/pdf"}]}, "item_creator": {"attribute_name": "\u8457\u8005", "attribute_type": "creator", "attribute_value_mlt": [{"creatorNames": [{"creatorName": "Sakamoto, Junichi"}], "nameIdentifiers": [{"nameIdentifier": "15590", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Morita, Satoshi"}], "nameIdentifiers": [{"nameIdentifier": "15591", "nameIdentifierScheme": "WEKO"}]}]}, "item_files": {"attribute_name": "\u30d5\u30a1\u30a4\u30eb\u60c5\u5831", "attribute_type": "file", "attribute_value_mlt": [{"accessrole": "open_date", "date": [{"dateType": "Available", "dateValue": "2018-02-19"}], "displaytype": "detail", "download_preview_message": "", "file_order": 0, "filename": "p009-016.pdf", "filesize": [{"value": "181.8 kB"}], "format": "application/pdf", "future_date_message": "", "is_thumbnail": false, "licensetype": "license_free", "mimetype": "application/pdf", "size": 181800.0, "url": {"label": "p009-016.pdf", "url": "https://nagoya.repo.nii.ac.jp/record/5857/files/p009-016.pdf"}, "version_id": "d40d0312-8ea8-489e-ae82-7dbf2e6ba3a1"}]}, "item_keyword": {"attribute_name": "\u30ad\u30fc\u30ef\u30fc\u30c9", "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": "\u8a00\u8a9e", "attribute_value_mlt": [{"subitem_language": "eng"}]}, "item_resource_type": {"attribute_name": "\u8cc7\u6e90\u30bf\u30a4\u30d7", "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": "\u30bf\u30a4\u30c8\u30eb", "attribute_value_mlt": [{"subitem_title": "From Translational Research to a Large Randomized Clinical Trial : A Long and Streanuous Way from Bench to Bedside"}]}, "item_type_id": "9", "owner": "1", "path": ["499/508/509/729"], "permalink_uri": "https://doi.org/10.18999/nagjms.69.1-2.9", "pubdate": {"attribute_name": "\u516c\u958b\u65e5", "attribute_name_i18n": "\u516c\u958b\u65e5", "attribute_value": "2007-03-19"}, "publish_date": "2007-03-19", "publish_status": "0", "recid": "5857", "relation": {}, "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_shared_id": null}