Clinical safety data management in company non-sponsored trials
Saito, A.; Sakai, J.; Kurihara, M.; Kami, M.; Kanda, Y.; Mori, S-ichiro.; Takaue, Y.; Ohashi, Y.
Nihon Rinsho. Japanese Journal of Clinical Medicine 61(9): 1658-1665
2003
ISSN/ISBN: 0047-1852 PMID: 14515738 Document Number: 564204
There is currently no harmonized way in Japan to manage safety data which are obtained during clinical trials supported by Government funds. There are two types of clinical trials, 'sponsored trials(sponsored by industrial companies)' and 'non-sponsored trials(funded by the Government, etc.)'. The Japanese Ministry of Health and Welfare has issued many of pharmaceutical laws(GCP, GPMSP etc.) for the regulation of sponsored trials, while none has ever established for non-sponsored trials, thus leaving the most important quality control/assurance unregulated. In this manuscript we discuss that the simple application of pharmaceutical laws to government-sponsored trials can not be a proper answer because of the different nature of the two types of trials.