Clinical trial system and its development in Japan
Journal Title: Journal of Analytical Bio-Science - Year 2012, Vol 35, Issue 5
Abstract
The efficacy and safety information of investigational new drugs are collected in compliance with the Ministerial Ordinance on Good Clinical Practice for Drugs (GCP) in order to assure their ethics, reliability, and scientific precision. After the enforcement of the GCP in 1997, the number of clinical trials has markedly decreased in Japan, resulting in the demise of clinical trials. Furthermore, a virtual ''valley of death'' exists between basic and clinical research in Japan. Since the Japanese are weak in clinical research compared with basic research. The demise of clinical trials is the cause of drug-lag problems, which means that some drugs already on the market in foreign countries cannot be used in Japan, since they are not approved at home. The number of clinical trials has been increasing due to recent Clinical Trial Activation Plans established by the Ministry of Education, Culture, Sports, Science and Technology, and by the Ministry of Health, Labour and Welfare. However, the number of clinical trials involving humans, investigator-initiated clinical trials, and multinational clinical trials remains low. Therefore, the activation of such trials is essential to fundamentally solving the drug-lag problem.
Authors and Affiliations
Tomoko Arai
Keywords
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