The volume of clinical research carried out in Japan is relatively small by global standards, especially when compared with the country's contributions to basic research. Although the academic quality of the clinical research done here is generally high, its relative paucity has had a number of alarming consequences, e.g., delays in the approval of important new drugs and medical devices caused by difficulties in clinical trials, leading to the limited availability of novel treatments for Japanese patients. This article aims to present an overview of current clinical research activities in Japan and to summarise the historical, socio-cultural and regulatory issues underlying the current situation. Suggestions are made as to how the present problems might be resolved and how a brighter future for clinical research might be achieved.
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