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臨床研究の歴史的背景・制度・実施体制に関する日米英の比較とわが国における改善策
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JPY
Abstract
Background Finding stronger evidence in clinical research is important for improving the quality of medical care, and more importantly, for protecting national health. However, the clinical research system in Japan appears immature relative to those in the United States and Europe. To explore how clinical research in Japan can be improved, we conducted a comparative survey on the present status of clinical research in various locations. Methods We reviewed the existing literature on the historical background, systems, and frameworks of clinical research in Japan, the United States, and the United Kingdom. Results Commitments must be made to support and protect study participants, ethical committees, and researchers;to secure adequate government funds;and to establish an information sharing system among researchers, government, and the public. Conclusion It is important to establish a framework for the duties of the government and central organization toward supporting clinical research and training researchers to improve the quality of medical care.
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