| ●Editorial | Kurihara M | 6-7 | Full text | |
| ●The past, present and future of bioethics and research ethics (Part II) | ||||
| Ensure reliability of clinical trials: Considering ICH-GCP(R2) and the system of clinical trial in Japan | Kono K | 9-20 | Abstract | |
| Proposals on “Clinical Research Implementation Standard” stipulated in Article 3 and other issues of the Draft Clinical Research Act submitted to the 190th Diet (Ordinary Session) | Pharmaceutical and Medical Device Regulatory Science Society of Japan | 21-4 | Abstract | |
| How to assess “spin” in randomized controlled trials: A call to action for all stakeholders | Okumura Y | 25-34 | Full text | |
| Lessons learned from the tragic case in Renne | Kumagai Y，Momma T | 35-44 | Abstract | |
| Puzzling out the tragedy of Rennes: The death of a healthy volunteer in the first-in-human trial in France | Kurihara C，Saio T， Nudeshima J | 45-65 | Abstract | |
| 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－ | Summers EI，Kiskaddon SH （Interview and trans. by Kurihara C） | 67-79 | Abstract | |
| On the Korean Guideline for Clinical Trial and the Human Research Protection Program | Kurihara C，Rhee Y | 81-5 | Abstract | |
| Guideline for Clinical Trial and the Human Research Protection Program | Clinical Trial Management Division, Pharmaceutical Safety Bureau, Ministry of Food and Drug Safety, Republic of Korea （trans. by Rhee Y，Kurihara C） | 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 |
91-194 | Abstract | ||
| Welcome and opening remarks; Infrastructure and activity of biotechnology development in Taiwan | Yang PC | 95-8 | ||
| ARO's strategy and actions in translational research | Nakanishi Y | 99-100 | ||
| Welcoming remarks | Wang AH | 101 | ||
| Novel therapeutics for mental disorders and Alzheimer's disease: Consortium for Mental Disorders (CMD) |
Lane HY | 102-5 | ||
| Elucidate the etiopathology of mental disorders: To overcome the psychopharmacology in crisis | Ozaki N | 106-9 | ||
| Oncology Phase I Consortium and international collaboration | Lin JCC | 110 | ||
| Early clinical development in EPOC (NCC & NCCE) | Doi T | 111-4 | ||
| Clinical and translation research for lung cancer in Taiwan | Yang JC | 115-8 | ||
| A nationwide genomic screening project in Japan (LC-SCRUM-Japan) | Goto K | 119-23 | ||
| GI Disease Consortium & designing reliable therapy for mass eradication of H. pylori to prevent gastric cancer in Taiwan |
Wu MS | 124-7 | ||
| Precision epigenetic risk diagnosis after mass eradication of H. pylori | Ushijima T | 128-9 | ||
| Investigator-Initiated Trials and Translational Research in NICR/TCOG －Focusing on non-CRC GI Cancers |
Chen LT | 130-4 | ||
| 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 |
Hirota M | 135-8 | ||
| Registry and biobank for rare cancer in Japan: Gastrointestinal stromal tumor, sarcoma and neuroendocrine tumor |
Nishida T | 139-42 | ||
| Early cancer drug discovery and development in academic setting clinical development in EPOC (NCC & NCCE) |
Yen Y | 143-6 | ||
| New strategy for cancer immunotherapy | Kaneda Y | 147-50 | ||
| Nano-Oncology: From nano scale molecular structure and dynamic analysis to new therapeutics and theranostics engineering |
Shieh DB | 151-3 | ||
| Immune-escape polymeric micelles carrying radionuclides as theranostic agent for breast cancer | Kimura S | 154-8 | ||
| Developing novel cancer imaging in Taiwan | Chang YC | 159-63 | ||
| PET screening study for early detection of cancer and its long-term follow-up | Kojima S | 164-6 | ||
| Current status for the surgery of colorectal cancer in Taiwan | Liang JT | 167-70 | ||
| Standardization of colon cancer surgery | Sugihara K | 171-4 | ||
| Drug development for hepatocellular carcinoma in Taiwan: A decade of evolution | Cheng AL | 175 | ||
| The present and future of Taiwanese Gynecologic Oncology Group (TGOG) | Wang KL | 176-9 | ||
| JGOG's activities | Okamoto A | 180-3 | ||
| Taiwan Biobank for the health of the next generations | Shen CY | 184-8 | ||
| Biobank and informatics for cancer projects and clinical sequencing at Kyoto University Cancer Center |
Muto M | 189-93 | ||
| General discussion organization | Liu FT | 194 | ||
| ●ASIA ARO Network Workshop －The 4th Annual Japan ARO Council Meeting:Global ARO network building－ Organized by：Academic Research Organization Council Chairman：Myoui A，Nishimura T |
195-240 | Abstract | ||
| Opening remarks | Myoui A | 197 | ||
| Structure, functions, and activities of Medical Research Collaborating Center | Kim HS，Lee J | 198-201 | ||
| ARO at Asan Medical Center－Collaboration with local AROs | Beck SH | 202-4 | ||
| KoNECT and KoNECT Collaboration Center: Fostering global clinical development in Korea | Chee D | 205-7 | ||
| Mutual use of e-IRB system for Korea - Japan Research Cooperation | Cho H，Rhee Y | 208-12 | ||
| Structure, functions and actives of NRPB in Taiwan | Wu MS | 213-5 | ||
| Taiwan Biobank and Biosignature Consortia | Liu FT | 216-8 | ||
| Singapore ARO structure and research operational strategy | Hui DHY | 219-23 | ||
| Overview of Japanese ARO Network | Nakanishi Y | 224-7 | ||
| Supporting system for translational research and medical innovation in Osaka University Hospital | Okada K | 228-31 | ||
| New oncology agents development in NCC | Ohtsu A | 232-5 | ||
| ARO activity and achievements of Tohoku University Hospital | Takano T | 236-8 | ||
| Closing remarks | Fukushima M | 239-40 | ||
| ●In Memoriam: Naokata Shimizu | Kurihara M | 241-2 | ||
| ●Instructions for authors［Japanese］ & ［English］ | 243-51 | Full text | ||
| ●Editor's note | Tsutani K | 253 | Full text | |
| ［Electronic publications only］ | ||||
| ●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－ |
Summers EI，Kiskaddon SH （Interview by Kurihara C） |
255-67 W1-W13 | Full text | |