title: [Participation to international registration trials--from the investigator's standpoint].
abstract: 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.
authors.affiliation: Division of Gastrointestinal Oncology/Digestive Endoscopy, National Cancer Center Hospital East.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ohtsu
mesh_terms: D000970:Antineoplastic Agents; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D017277:Drug Approval; D006801:Humans; D007391:International Cooperation; D007564:Japan; D007723:Korea; D007880:Legislation, Drug
chemical_list: D000970:Antineoplastic Agents