Content and Classffication of Clinical Trials at a University Hospital in Japan.
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概要
- 論文の詳細を見る
"Standards on the Implementation of Clinical Trials on Drugs (New GCP)" is a Japanese government policy established in April 1998 with the aim of satisfying scientific and ethical requirements for industry-sponsored research, i.e., registration-directed clinical trials and clinical trials intended to support reexamination or reevaluation applications. Since then, efforts for more effective implementation of clinical trials have been promoted, including establishment of a system to invite more active participation of subjects in clinical trials and improvement of a network of medical institutions conducting clinical trials. These efforts should help to reactivate clinical trials in Japan, which reportedly have become stagnant. Although the New GCP addresses the quality of industry-sponsored clinical trials, investigators also construct study protocols without industry involvement. We reviewed clinical trials submitted by investigators at Gunma University Hospital to institutional review boards (IRBs) from June 1999 to February 2002. Ten clinical research coordinators contributed to the present survey. A total of 151 investigator-initiated clinical trials reviewed included a wide variety of content; and investigators from many institutions and organizations conducted trials. Most of the ethical guidelines for approving proposed trials represented the provisions of the Declaration of Helsinki. However, additional guidelines prepared by the Japanese Ministry of Health, Labour and Welfare were also helpful. Development of a support system for clinical trails requires the contribution of clinical research coordinators. Flexible management and careful attention to both the protocol and its execution by the investigators were also important for promoting clinical trials on the basis of meticulous patient care.
- International Heart Journal刊行会の論文
著者
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Nakamura Tetsuya
Clinical Investigation And Research Unit Gunma University Hospital
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Nagai Ryozo
Department Cardiovascular Medicine The University Of Tokyo Hospital
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Horiuchi Ryuya
Clinical Investigation and Research Unit, Gunma University Hospital
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Yamamoto Koujirou
Clinical Investigation and Research Unit, Gunma University Hospital
関連論文
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- Comparison of Oral and Transdermal Hormone Replacement Therapy on Arterial Stiffness and Vascular Inflammatory Markers in Postmenopausal Women (Preventive Medicine/Epidemiology/Education/Health Policy 5 (H), The 69th Annual Scientific Meeting of the Japan
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- PJ-436 Impaired Vascular Endothelial Function in Postmenopausal Women with Osteoporosis(Atherosclerosis, clinical-13, The 71st Annual Scientific Meeting of the Japanese Circulation Society)
- PJ-435 Raloxifene is Effective for Reducing Carotid Artery Wall Thickness and Increasing Bone Mineral Density in Postmenopausal Women with Osteoporosis(Atherosclerosis, clinical-13, The 71st Annual Scientific Meeting of the Japanese Circulation Society)
- Transdermal Hormone Replacement Therapy Reduces Carotid Artery Wall Thickness and Levels of Vascular Inflammatory Markers in Postmenopausal Women (Preventive Medicine/Epidemiology/Education/Health Policy 6 (H), The 69th Annual Scientific Meeting of the Ja
- Comparison of Oral and Transdermal Hormone Replacement Therapy on Arterial Stiffness and Vascular Inflammatory Markers in Postmenopausal Women (Preventive Medicine/Epidemiology/Education/Health Policy 5 (H), The 69th Annual Scientific Meeting of the Japan
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- OE-173 A Novel Regulatory Pathway of DNA Damage Response to Pathologic Vascular Injury as Mediated by KLF5 and its Transcriptional Complexes(Molecular biology, vascular-2, The 71st Annual Scientific Meeting of the Japanese Circulation Society)
- OE-048 Angiotensin II Activates the DNA Damage Response through Nitric Oxide in Vascular Endothelial Cells(Cardiac hypertrophy, basic/clinical-1, The 71st Annual Scientific Meeting of the Japanese Circulation Society)
- OE-008 Cellular Proteomic Approach to Identify Transforming Growth Factor (TGF)-beta Induced DNA and/or RNA-binding Factors(Molecular biology, vascular-1, The 71st Annual Scientific Meeting of the Japanese Circulation Society)
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- The Cardiovascular Transcription Factor Kruppel-like Factor 5 is Negatively Regulated by the Deacetylase HDAC1 through Direct Interaction(Molecular Biology, Vascular 1 (H), The 69th Annual Scientific Meeting of the Japanese Circulation Society)
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- OE-174 Molecular Mechanism of Soluble Form of VEGFR-1 (sVEGFR-1)Expression in Vascular Endothelial Cell(Molecular biology, vascular(01)(IHD),Oral Presentation(English),The 72nd Annual Scientific Meeting of the Japanese Circulation Society)
- OE-044 Long Pentraxin 3 (PTX3) is More Specific than C-reactive Protein (CRP) as a Marker for Vascular Inflammation(Atherosclerosis, clinical-01, The 71st Annual Scientific Meeting of the Japanese Circulation Society)
- OE-019 Peripheral Clock Regulates Circadian Thrombomodulin Gene Expression in Vascular Endothelial Cells(Molecular biology, vascular-1 (H) OE4,Oral Presentation (English),The 70th Anniversary Annual Scientific Meeting of the Japanese Circulation Society)
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- Characteristic Effects of α1-β_1,2-Adrenergic Blocking Agent, Carvedilol, on [Ca^2+]_i in Ventricular Myocytes Compared With Those of Timolol and Atenolol
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- Content and Classffication of Clinical Trials at a University Hospital in Japan.