| ●Editorial | Ohashi K | 480-1 | Full text | |
| ●The 3rd International Symposium of Early Stage Clinical Trial Early stage clinical trials on patients Organized by：Clinical Pharmacology Center, Oita University Hospital Department of Pharmacology, St. Marianna University School of Medicine Clinical Trial Support Unit, St. Marianna University Hospital The Organizer of the Executive Committee：Matsumoto N | 483-549 | Abstract | ||
| Welcome and opening remarks | Ohashi K | 485 | ||
| Outcome report of core clinical research center at Oita University ─ Aiming for the All-Japan establishment on early stage clinical trial conduct ─ | Ohashi K | 486-91 | ||
| Overcoming obstacles in clinical trial design: The MS experience | Cortese I | 492-503 | Full text | |
| Search for a model of drug efficacy for a rare chronic progressive neurological disease HAM | Yamano Y | 504-8 | ||
| Endpoints and biomarkers in clinical trial of neurological disorders | Katsuno M | 509-15 | ||
| How to use surrogate endpoints in drug evaluation | Komiyama O | 516-21 | ||
| Discussion | 522-6 | |||
| Adipose-derived regenerative cells ─ Bench to bedside ─ | Iwaguro H | 527-32 | ||
| Clinical and Regulatory Development of Vascular Regeneration Therapy for Critical Limb Ischemia | Kawamoto A | 533-9 | ||
| Promotion of clinical trials using human stem cells toward practical use | Imai K | 540-4 | ||
| Discussion | 545-8 | |||
| Closing remarks | Matsumoto N | 549 | ||
| ●Urgent special topic Opinions on the concept paper of integrating epidemiological and clinical guidelines | ||||
| How clinical research in Japan must be done in the future ─ In response to the interim summary of issues on the review of Ethical Guidelines for Epidemiological Research and Clinical Research ─ | Tsuda S，Noguchi T，Doi O | 551-8 | Abstract | |
| Prerequisites to reclaim global reliance on academic clinical trials in Japan | Nagai Y，Kagimura T，Kikuchi T，et al． | 559-74 | Abstract | |
| Proposal from JAPhMed to improve research integrity upon revision of ethics guidance | Kitagawa M，Iwasaki K， Iwamoto K，Imamura K | 575-9 | Abstract | |
| The rights of the human research subject and the ethical guidelines ─ Mini-GCP? Ethical norms? What is our future? ─ | Kurihara C | 581-7 | Full text | |
| ●Interview | ||||
| Adoption of the 2013 revision of the Declaration of Helsinki ─ Interview with Dr. Masami Ishii, Executive Board Member of the Japan Medical Association ─ | Ishii M (Interview by Kurihara C) | 589-96 | Abstract | |
| ●Articles | ||||
| Regulatory science: An emerging new scientific discipline | Moghissi AA，Stough RS，Inutsuka T，et al． | 597-608 | Abstract | |
| Significance of biomarkers with future prospects for ethical guidelines for clinical studies from the history of translational research | Imamura O，Takano T，Shimokawa H | 609-17 | Abstract | |
| Odds and sods among the geese when the gander is away: Reviewing Japanese psychopolitics | Saio T，Sakurazawa H | 619-26 | Full text | |
| ●Translation | ||||
| Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products［draft guidance］ U.S. Department of Health and Human Services, Food and Drug Administration（FDA）， Center for Biologics Evaluation and Research（CBER） | （trans. by Nishimura H，Noguchi Y） | 627-44 | ||
| ●In Memoriam: Masakuni Kameyama | Kurihara M | 645 | ||
| ●Instructions for authors［Japanese］＆［English］ | 647-55 | Full text | ||
| ●Editor’s note | Kurihara M | 657 | Full text | |