| ●Editorial | Kurihara M | 662-3 | Full text | |
| ●Reformation of clinical research and medical innovation policies in Japan: Challenges and opportunities | ||||
| Round table discussion: Reformation of clinical research and medical innovation policies in Japan: Challenges and opportunities | Izumi H，Kondo T， Fukushima M，Inoue T （Organized by Kurihara C） | 665-98 | Abstract | |
| ●Reflecting on the credibility of investigator-initiated clinical trials | ||||
| Future clinical trials of post-marketing drugs in Japan: Lessons to learn from the Diovan (valsartan) scandal and proposal for a solution | Nakano S | 699-714 | Abstract | |
| Misconduct in investigator-initiated clinical trials on antihypertensive drugs and the future of clinical trials in Japan | Kageyama S | 715-22 | Abstract | |
| Standard of Practice for Statisticians: Recent activities by the Biometric Society of Japan | Tsubaki H | 723-31 | Abstract | |
| Continuing education of clinical trial statisticians: An incident after a sham trial involving a hypertensive drug | Takahashi Y | 733-58 | Abstract | |
| Decipherment of the retracted articles on valsartan trials in Japan: On the fundamental flaws untold | Saio T | 759-68 | Full text | |
| What needs to be done for the future of clinical research? ─Introducing an urgent statement by JAPhMed─ | Imamura K | 769-72 | Abstract | |
| What should be done to tackle the issues raised by the Diovan data-manipulation
scandal? ─Proposals from Medwatcher Japan─ | Minaguchi M | 773-87 | Abstract | |
| The Valsartan (Diovan®) Scandal: The view from inside journalism | Kawachi T，Hatta K | 789-97 | Abstract | |
| The “Valsartan Scandal” ─An ethical regulatory and policy analysis to
ensure the protection of human subjects and the integrity of clinical research in Japan | Kurihara C，Saio T | 799-815 | Full text | |
| ●The regulations and credibility of investigator-initiated clinical trials in the United States and Europe | ||||
| FDA regulatory trends and challenges, and ACRP’s role in the regulatory realm | Thomasell JD | 817-23 | Abstract | |
| Clinical trials and pharmaceutical industry: An insight into their regulation in France and Europe as of early 2014 | Prescrire Editorial Staff | 825-35 | Abstract | |
| ●Original | ||||
| The issue of compensation of clinical trial subjects in Japan: The rimonabant lawsuit and the Ihoken Clinical Trial Compensation Guideline 2009 | Tsuji J | 837-62 | Abstract | |
| ●Translations | ||||
| Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) ─ Determining Whether Human Research Studies Can Be Conducted Without an IND U.S. Department of Health and Human Services, Food and Drug Administration， Center for Drug Evaluation and Research（CDER），Center for Biologics Evaluation and Research（CBER）， Center for Food Safety and Applied Nutrition（CFSAN） | （trans. by Nishimura H， Nagai Y） | 863-82 | ||
| Guidance for Industry: Preclinical Assessment of Investigational Cellular
and Gene Therapy Products U.S. Department of Health and Human Services, Food and Drug Administration， Center for Biologics Evaluation and Research | （trans. by Nishimura H， Kimura Y，Noguchi Y） | 883-906 | ||
| Nonclinical data required for clinical application of induced pluripotent stem cells (iPSCs)-based products ─Critique of Japanese Notifications compared with the policies of FDA and EMA─ |
Kimura Y，Nishimura H， Kurihara C，Fukushima M | 907-21 | Full text | |
| ●Forum | ||||
| For the civic participation in planning of the clinical trial | Asano Y | 923-6 | ||
| Rebate debate: Private clinic physicians’ perspective on the Dual Punishment System in Korea | Hong SS | 927-8 | ||
| ●In Memoriam: Keiji Ueda | Kurokawa T | 929 | ||
| ●Instructions for authors［Japanese］＆［English］ | 931-9 | Full text | ||
| ●Editor’s note | Fukushima M | 941 | Full text | |