title: [Introduction "why is it multinational clinical trial now?"].
abstract: In spite of having developed first in Japan, we approved oxaliplatine last year behind Western countries with long delay. The problem of the drug lag in an anticancer drug is very serious, if you want to cancel somehow, now, is desperate, and considers this. Both regulatory authority and pharmaceutical industry approved of making the forum to which industry, academia and government meet together. Everyone on this first meeting, we should have a discussion from various angles and considered about the clinical development of an anticancer drug that the motion in recent years which is going to aim at world simultaneous development by multinational clinical trial with the West and the Asia neighboring countries wants to explore the way where our country can free itself from the situation of the circumference delay from the West at an early stage.
authors.affiliation: Center for Product Review Pharmaceuticals Medical Devices Agency.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Mori
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D017277:Drug Approval; D004345:Drug Industry; D006076:Government; D006801:Humans; D007391:International Cooperation; D015337:Multicenter Studies as Topic; D009944:Organoplatinum Compounds / Q000627:therapeutic use*; D000077150:Oxaliplatin
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin