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
The new technology to improve specificity of immunochromatography
Immunochromatography is one of the assays which are well known and used in clinical setting. To compare with the other assay, its rapidness, easy handling and inexpensive cost are being mentioned for its advantages. Howe...
Difference of inhibitory effect of α-glucosidase by tealeaves species and extraction condition and effect of black tea on postprandial blood glucose level elevation in ICR mice
Inhibitory effects in vitro of α-glucosidase within various kinds of black tea leaves were evaluated. Comparison of 24 different black tea leaves showed that the Uva is the most effective black tea for α-glucosidase inhi...
The present state and problems of a Global Clinical Trial Study
A Global Clinical Trial Study is an important trial for drug rag cancellations. The environment in Japan to smoothly advance a Global Clinical Trial Study is now underway. As a result, the number of Global Clinical Trial...
Development of protein extraction method from urinary calculus and identification of protein in calculus extract
Correct extraction of proteins contained within the calculi of urolithiasis patients is important to correctly identify these diverse proteins. Based on protein extraction solutions previously reported, we developed an e...
Albumin-like reactivity of amphoteric and cationic surfactants toward BCG color reagents
Bromocresol Green (BCG) dyes exist as an equal mixture of undissociated (λmax 450 nm) and dissociated (λmax 620 nm) dye forms in acid solutions. In BCG color reagents for measuring serum albumin, color development of th...