| ●Editorial | Ueda K | 4-6 |
| ●Quality assurance of investigator-oriented clinical research in Japan -Current status and efforts towards future development- | ||
| ・The current status of infrastructure of investigator-oriented clinical research in Japan and efforts towards future development | ||
| Establishment of the EBM Center and its project CASE-J －Towards the realization of quality assured clinical research－ | Fukui T | 7-25 |
| Clinical implications of the Japanese Trial to Assess Optimal Systolic Blood Pressure in Elderly Hypertensive Patients（JATOS） | Ishii M, Goto Y | 27-34 |
| State of the art trials | Watanabe T, Ohashi Y, Amari H | 35-41 |
| Clinical trial of acupuncture－Methodological and practical issues | Tsukayama H, Yamashita H | 43-51 |
| Hospital information system with management to clinical trials for EBM | Akiyama M | 53-9 |
| The requirements for medical research－Principle, system and human resources | Sato K | 61-9 |
| On the required infrastructure of the current use of human materials and information in biomedical research in Japan | Masui T | 71-82 |
| Round table discussion：Perspectives for reliable and ethical conduct of investigator-oriented clinical research | Rinsho Hyoka Editorial Committee | 83-97 |
| ●Topics | ||
| The 2000 revision of the Declaration of Helsinki and its implications in medical ethics －Interview with the WMA Immediate Past President, Eitaka Tsuboi－ | Tsuboi E | 99-107 |
| ●Scientific and ethical integrity of clinical research | ||
| The role of journal editors in promoting research integrity | Yamazaki S | 109-14 |
| GCP inspection andwithdrawal of a study report | Adachi M | 115-6 |
| CONSORT and STARD－Movements for the improvement of clinical research reporting | Saio T | 117-28 |
| Explanatory introduction to the French Act for protection of human research participants | Nudeshima J, Kurihara C, Mitsuishi T | 129-34 |
| Material | ||
| Code de la Santé Publique Première Parti, Livre Ier Titre Ⅱ. Recherches biomédicales | (trans. by Mitsuishi T, Nudeshima J, Kurihara C) | 135-42 |
| Special Article：Is the placebo powerless? :An analysis of clinical trials comparing placebo with no treatment | Hróbjartsson A，Gøtzsche PC (trans. by Kobayashi T, Kurihara C, Tsutani K) | 143-57 |
| The powerful placebo and the wizard of Oz | Bailar Ⅲ JC (trans. by Kobayashi T, Kurihara C, Tsutani K) | 159-62 |
| The revised CONSORT statement for reporting randomized trials: Explanation and elaboration | Altman DG，Schulz KF, Moher D，et.al. (trans. by Tsutani K, Kurihara C) | 163-208 |
| ●Forum | ||
| A letter to Ann of Intern Med on CONSORT | Yuasa H | 209-10 |
| On the evidence of EBM | Yokota Y | 210-2 |
| Issues of Investigator-oriented IND (investigational New Drug) studies | M・H | 212-3 |
| This is not a pipe: structuralism and medicine?…What now? | Tei G | 214-6 |
| ●Instructions for authors [English] | 217-22 | |
| ●Editor's note | Kurihara M | 223 |