| ●Editorial | Kurokawa T | 4 |
| ●New trend of clinical trial and clinical research | ||
| Investigator-initiated clinical trials in Japan: Present and future | Watanabe H，Kageyama S，Kusuoka H，et al. | 5-18 |
| The reform of the Evaluation System of Investigational Medical Care | Miyata T | 19-22 |
| Toward higher-quality medical care: Necessity of “Civic participation type medical treatment” and “Basic Law for clinical study” in Japan | Nakano S | 23-33 |
| Clinical trial regulation and economic evaluation of IND introduction in Japan | Kawakami K | 35-42 |
| Future perspective of clinical research－Proposals from JAPhMed－ | Iwamoto K，Kitagawa M，Inoue M | 43-51 |
| Involving patients and incorporating lay perspectives into clinical trials | Beppu H，Mutoh K | 53-70 |
| 2012 Revision of the French Law on Research involving Human Being －Reorganization of clinical research categories and regulations－ | Nudeshima J | 71-7 |
| Revision of Bioethics and Safety Act in South Korea －Comprehensive system of human research subjects protection and quality assurance of research, comparing with Japan－ ・Full text version in English is here ! | Kurihara C | 79-90 |
| ●CDISC as the global standards | ||
| Extracting the value of standards: The role of CDISC in a pharmaceutical research strategy ・Full text version in English is here ! | Rockhold FW，Bishop S | 91-6 |
| ●The 10th Setouchi International Conference on Clinical Trials Organizers：Nomoto M，Kageyama S，Araki H，Ohashi K，Nakamura T | 97-177 | |
| Opening remarks | Nomoto M | 99 |
| Premarketing clinical evaluation of proarrhythmic potential for new drugs ～Implementation of ICH E14 guideline in Japan | Shinagawa K | 100-10 |
| Summary of the results of QT-prolonging drugs in non-clinical studies | Sugiyama A | 111-8 |
| Genetic background of drug-induced QT interval prolongation | Horie M | 119-22 |
| Long QT syndrome | Nagai T | 123-8 |
| QT interval change with age | Nagai M | 129-32 |
| From a perspective of industries | Iwasaki M | 133-8 |
| From CRC's viewpoint | Yamashita R | 139-43 |
| Therapeutic drugs on metabolic disorders: Focusing on diabetes | Kageyama S | 144-9 |
| Clinical trials on neurological disorders | Nomoto M | 150-5 |
| Respiratory diseases: Present status and future of drug development | Yanagawa H | 156-61 |
| Guidance (draft) for establishing safety in first-in-human studies during drug development | Kobayashi S | 162-7 |
| Difference between Japan and overseas countries on the situation of first-in-human (FIH) study | Iwasaki K | 168-71 |
| Mechanisms and strategies for drug-induced anaphylaxis | Aibiki M | 172-6 |
| Closing remarks | Kageyama S | 177 |
| ●Articles | ||
| The central laboratory tests system in clinical trials: From the results of a questionnaire survey of physicians participating in the ASUCA Trial | Todo S，Ueshima K，Kobayashi J，et al. | 179-85 |
| Background factors of the participating physicians and patients enrollment: From the results of a questionnaire survey for physicians participating in the SAKURA trial | Nakamoto M，Ueshima K，Fukutomi M，et al. | 187-92 |
| On the possibility of abuse of supplements containing lithium | Saio T | 193-8 |
| ●Translation | ||
| Application of GRADE: Making evidence-based recommendations about diagnostic tests in clinical practice guidelines | Hsu J，Brożek JL，Terracciano L，et al. （trans. by Aihara M） | 199-212 |
| ●In Memoriam: Koichi Yamamoto | Kurihara M | 213 |
| ●Forum | ||
| Werther effect and Papageno effect | Saio T | 215-20 |
| ●Instructions for authors [Japanese] & [English] | 221-9 | |
| ●Editor's note | Nudeshima J | 231 |