Ohtsu Atsushi
Division of Gastrointestinal Oncology/Digestive Endoscopy, National Cancer Center Hospital East.
Gan To Kagaku Ryoho. 2007 Feb;34(2):297-300.
Clinical developments of new anti-cancer drugs in Japan are far behind from the Western as well as Asian countries, which resulted in much delay for indicating them into Japanese patients. The causes of delay are considered to exist in regulatory authorities, pharmaceutical companies, and investigators, respectively. However, these delays have recently been improved by the revision of Japanese regulatory guidelines with an activity of committee for this issue. After overcoming various issues, two global registration studies involving Japanese institutions have already been initiated and additional global studies are now conducting in the field of gastrointestinal (GI) cancer in Japan. A Japan-Korea joint phase I study of new agent for gastric cancer is also now being conducted. It is time for Japanese GI investigators to recover the delay in new drug development and to make an effort for new evidence originated from Japan.
日本新型抗癌药物的临床研发远远落后于西方国家和亚洲其他国家，这导致这些药物在日本患者中的获批时间大幅延迟。延迟的原因分别被认为存在于监管机构、制药公司和研究人员身上。不过，通过日本监管指南的修订以及针对此问题的委员会活动，这些延迟情况最近有所改善。在克服各种问题之后，两项涉及日本机构的全球注册研究已经启动，并且日本目前正在胃肠（GI）癌领域开展更多全球研究。一项日本 - 韩国联合的胃癌新药I期研究目前也正在进行。现在是日本胃肠病研究人员弥补新药研发延迟并努力获取源自日本的新证据的时候了。
