| ●Editorial | Kageyama S | 4-5 |
| ●ARO and IRB: Future of business-academia collaboration | ||
| ・Status and future of AROs (academic research organizations) | ||
| Round table discussion: Academic Research Organizations (ARO) for clinical trials in Japan−Current situation and prospects | Uchida E, Tateishi T, Kumagai Y, et al. | 7-30 |
| The second symposium on translational research at Kyoto University Organized by： Translational Research Center, Kyoto University Hospital R&D and Corporate Integration, Kyoto University Hospital | 31-107 | |
| Round table discussion: Development of New Medicines for Neglected Diseases | Croft SL, Yamada H, Otoguro K, et al. | 109-35 |
| ・The central institutional review board (IRB) and IRB member education | ||
| Questionnaire Survey for the Improvement of GCP: Motivations towards a Central IRB and simplification of adverse event reporting | Ohashi K, Ueda K, Kageyama S, et al. | 137-52 |
| Task force survey for the improvement of GCP towards a Central IRB and other administrative simplifications: European Union (EU), United States (US), and Japan | Kageyama S, Watanabe H, Kurihara C, et al. | 153-76 |
| The first IRB Training Forum: Planning and Outcomes | Kurihara C, Matsumoto K, Saio T, et al. | 177-99 |
| Workshop on IRB in Kanazawa: establishing a regional IRB within the Ishikawa Medical Association and pursuing an ideal partnership with regional hospitals | Inano A, Kondo K, Umeda T | 201-12 |
| ●Original | ||
| Study on development and evaluation of new over-the-counter drugs by the actual use trial (AUT) using OTC common cold medicine including ibuprofen | Shimizu N, Notani J, Nishikawa T, et al. | 213-40 |
| Logarithmic equation in Japanese drug pricing rules as a main determinant of the abrupt price rising of growth hormone products | Kamada I, Saio T | 241-7 |
| ●Topics | ||
| Clinical trial registration and research integrity −Interview with Harold C. Sox, the editor-in-chief, (Annals of Internal Medicine) | Sox HC | 249-57 |
| ●Material | ||
| From philosophical psychopathology to positivistic psychometrics | Saio T | 259-60 |
| The Dictionary of Disorder: how one man revolutionized psychiatry | Spiegel A (trans. by Saio T) | 261-70 |
| ●Forum | ||
| 『GCP (Good Clinical Practice) Handbook, 3rd. ed.』 | Kobayashi S | 271-2 |
| ●Instructions for authors [English] | 273-8 | |
| ●Editor's note | Uchida E | 279 |