臨 床 評 価
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●特集:5th World Centenarian Initiative 脳卒中予防・治療戦略国際シンポジウム,生命倫理と研究倫理の過去・現在・未来(第3回)
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●特集:生命倫理と研究倫理の過去・現在・未来(第2回),2nd Taiwan-Japan ARO Workshop,ASIA ARO Network Workshop
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UP日
2017.04.25 Vol.45, No.1, Apr. 2017
生命倫理と研究倫理の過去・現在・未来(第2回)/2nd Taiwan-Japan Academic Research Organization Workshop/
ASIA ARO Network Workshop


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Vol.45, No.1, Apr. 2017
生命倫理と研究倫理の過去・現在・未来(第2回)/2nd Taiwan-Japan Academic Research Organization Workshop/
ASIA ARO Network Workshop

The past, present and future of bioethics and research ethics (Part II) / 2nd Taiwan-Japan Academic Research Organization Workshop /
ASIA ARO Network Workshop
 
目   次
 
巻頭言栗原 雅直6-7Full text
 
生命倫理と研究倫理の過去・現在・未来(第2回)   
・臨床研究の信頼性と公正性  
 原著:臨床試験の信頼性確保のために
  -ICH-GCP(R2)と日本における臨床研究法案をめぐる考察-
河野 健一9-20Abstract
 資料:第190回国会(常会)に提出された臨床研究法案第3条に規定する
  「臨床研究実施基準」等に関する提言について
(一財)医薬品医療機器
レギュラトリーサイエンス財団
21-4Abstract
 論説:粉飾された臨床試験の判別法:臨床試験のすべての関係者へ奥村 泰之25-34Full text
・フランス第Ⅰ相被験者死亡事故:「レンヌ事件」について  
 総説:レンヌ事件の教訓熊谷 雄治,門間  毅35-44Abstract
 原著:「レンヌ事件」について-フランスにおける第Ⅰ相試験死亡事故の教訓栗原千絵子,齊尾 武郎,
橳島 次郎
45-65Abstract
・研究対象者保護プログラムの最新動向  
 インタビュー:米国AAHRPP(研究対象者保護プログラム認証協会)
  Dr. Elyse I. Summers(会長・CEO),Dr. Sarah H. Kiskaddon(Director・Public Affairs)
   インタビュー:米国と世界の被験者保護システムの最近の動向
Elyse I. Summers,
Sarah H. Kiskaddon
(インタビュー・訳 栗原千絵子)
67-79Abstract
 解説:韓国における「臨床試験と対象者保護プログラム(HRPP)運営ガイドライン」について栗原千絵子,李  侖珍81-5Abstract
 翻訳:臨床試験と対象者保護プログラム(HRPP)運営ガイドライン韓国食品医薬品安全省
医薬品安全局 臨床制度課
(訳 李  侖珍,栗原千絵子)
87-90
 
2nd Taiwan-Japan Academic Research Organization Workshop
 -Cancer translational research and cancer registry studies-

       Sponsored and organized by:National Research Program for Biopharmaceuticals(NRPB), Taiwan;
                        Academic Research Organization Council, Japan
91-194Abstract
・Supportive platform/infrastructure;Opening remarks  
 Welcome and opening remarks;
  Infrastructure and activity of biotechnology development in Taiwan
Pan-Chyr Yang95-8
 ARO's strategy and actions in translational researchYoichi Nakanishi99-100
 Welcoming remarksAndrew H.-J. Wang101
・Session I:Mental diseases  
 Novel therapeutics for mental disorders and Alzheimer's disease:
  Consortium for Mental Disorders (CMD)
Hsien-Yuan Lane102-5
 Elucidate the etiopathology of mental disorders: To overcome the psychopharmacology in crisisNorio Ozaki106-9
・Session II:Oncology 1  
 Oncology Phase I Consortium and international collaborationJosh Chia-Chi Lin110
 Early clinical development in EPOC (NCC & NCCE)Toshihiko Doi111-4
 Clinical and translation research for lung cancer in TaiwanJames Chih-Hsin Yang115-8
 A nationwide genomic screening project in Japan (LC-SCRUM-Japan)Koichi Goto119-23
・Session III:Oncology 2 & cancer registry  
 GI Disease Consortium & designing reliable therapy for mass eradication of H. pylori
  to prevent gastric cancer in Taiwan
Ming-Shiang Wu124-7
 Precision epigenetic risk diagnosis after mass eradication of H. pyloriToshikazu Ushijima128-9
 Investigator-Initiated Trials and Translational Research in NICR/TCOG
  -Focusing on non-CRC GI Cancers
Li-Tzong Chen130-4
 Continuous regional arterial infusion (CRAI) versus venous infusion of nafamostat
  mesylate for severe acute pancreatitis: Background and study protocol
   for a multicenter randomized controlled trial by a Japanese study group
Morihisa Hirota135-8
 Registry and biobank for rare cancer in Japan:
  Gastrointestinal stromal tumor, sarcoma and neuroendocrine tumor
Toshirou Nishida139-42
・Session IV:Oncology 3  
 Early cancer drug discovery and development in academic setting clinical development
  in EPOC (NCC & NCCE)
Yun Yen143-6
 New strategy for cancer immunotherapyYasufumi Kaneda147-50
 Nano-Oncology: From nano scale molecular structure and dynamic analysis
  to new therapeutics and theranostics engineering
Dar-Bin Shieh151-3
 Immune-escape polymeric micelles carrying radionuclides as theranostic agent for breast cancer Shunsaku Kimura154-8
 Developing novel cancer imaging in TaiwanYeun-Chung Chang159-63
 PET screening study for early detection of cancer and its long-term follow-upShinsuke Kojima164-6
 Current status for the surgery of colorectal cancer in TaiwanJin-Tung Liang167-70
 Standardization of colon cancer surgeryKenichi Sugihara171-4
・Session V:Oncology 4 & biobanking  
 Drug development for hepatocellular carcinoma in Taiwan: A decade of evolutionAnn-Lii Cheng175
 The present and future of Taiwanese Gynecologic Oncology Group (TGOG)Kung-Liahng Wang176-9
 JGOG's activitiesAikou Okamoto180-3
 Taiwan Biobank for the health of the next generationsChen-Yang Shen184-8
 Biobank and informatics for cancer projects and clinical sequencing
  at Kyoto University Cancer Center
Manabu Muto189-93
 General discussion organizationFu-Tong Liu194
 
ASIA ARO Network Workshop
 -The 4th Annual Japan ARO Council Meeting:Global ARO network building-

       Organized by:Academic Research Organization Council
       Chairman:Akira Myoui,Tsutomu Nishimura
195-240Abstract
・1. Opening remarks  
 Opening remarksAkira Myoui197
・2. ARO structure, functions and activities in Korea  
 Structure, functions, and activities of Medical Research Collaborating Center Han-Suk Kim,Joongyub Lee198-201
 ARO at Asan Medical Center-Collaboration with local AROsSung-Ho Beck202-4
 KoNECT and KoNECT Collaboration Center: Fostering global clinical development in KoreaDeborah Chee205-7
 Mutual use of e-IRB system for Korea - Japan Research CooperationHyunin Cho,Younjin Rhee208-12
・3. ARO structure, functions and activities in Taiwan  
 Structure, functions and actives of NRPB in TaiwanMing-Shiang Wu213-5
 Taiwan Biobank and Biosignature ConsortiaFu-Tong Liu216-8
・4. ARO structure, functions and activities in Singapore 
 Singapore ARO structure and research operational strategyDamien Hong Yew Hui219-23
・5. Japan ARO network: Activity and achievements  
 Overview of Japanese ARO NetworkYoichi Nakanishi224-7
 Supporting system for translational research and medical innovation in Osaka University HospitalKiyoshi Okada228-31
 New oncology agents development in NCCAtsushi Ohtsu232-5
 ARO activity and achievements of Tohoku University HospitalTadao Takano236-8
・6. Discussion and closing remarks 
 Closing remarksMasanori Fukushima239-40
 
訃報  
 清水直容先生を悼む栗原 雅直241-2
 
投稿規定(和文・英文) 243-51Full text
 
編集後記 研究倫理年表の最初になにを記すべきか? 津谷喜一郎253Full text
 
[電子版のみ]
Interview
 Interview with Dr. Elyse I. Summers, President & CEO, and Dr. Sarah H. Kiskaddon,
  Director of Global Development & Public Affairs, Association for the Accreditation of
   Human Research Protection Program (AAHRPP)
    -Recent trend of human subject protection system in the U.S. and in the world-
Elyse I. Summers,
Sarah H. Kiskaddon
(Interview by Chieko Kurihara)
255-67
W1-W13
Full text


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