title: [Post launch studies].
abstract: Evidence Based Medicine (EBM) is a growing concept in Japan as it is elsewhere. Central to improving the use of EBM is generation of data through well conducted controlled clinical studies. There are many problems associated with conduct of clinical studies after launch in Japan, and many initiatives are ongoing to improve the situation. Development of Clinical Research Coordinators (CRO) and central Data Management centers are key to improving the quality of clinical research in Japan. Currently Japan has an undeveloped legal system with regard to post-launch trials and off-label use of registered drugs. There is no reimbursement for off-label and various restrictions imposed on the recipients of the Ministry of Health, Labour and Welfare's (MHLW) funds. Maybe the biggest problem is the high cost of post-marketing studies sponsored by pharmaceutical manufacturers. A high quality system to support post launch clinical studies need a solid financial base. There is a need for a suitable review system for investigator initiated multi-centre studies, as the current IRB system is not sufficient. There are also challenges regarding the differences, perceived or real, in treatment practice and available registrations in Japan and in the West, causing problems in choosing suitable comparators and study designs. At the present time it is not clear whether investigator initiated trials will be acceptable for registration purposes in Japan. The agreed first priority is to build a suitable and strong infrastructure within the academic community to support researchers to investigate important questions with or without pharmaceutical company support. Despite all these issues, several groundbreaking projects are under way throughout Japan, in many different areas and by different collaborative groups, some with government support. In fact, researcher-initiated clinical trials achieved a rapid growth in Japan in the past year.
authors.affiliation: Dept. of Urology, Institute of Clinical Medicine, University of Tsukuba, Japan.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Akaza
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimada
authors.forename: Tadashi
authors.initials: T
authors.lastname: Ikeda
authors.forename: Nagahiro
authors.initials: N
authors.lastname: Saijo
authors.forename: Seiji
authors.initials: S
authors.lastname: Isonishi
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Hirao
authors.forename: Takashi
authors.initials: T
authors.lastname: Tsuruo
authors.forename: Shigeru
authors.initials: S
authors.lastname: Tsukagoshi
authors.forename: Saburo
authors.initials: S
authors.lastname: Sone
authors.forename: Seigo
authors.initials: S
authors.lastname: Nakamura
authors.forename: Masuhiro
authors.initials: M
authors.lastname: Kato
authors.forename: Osamu
authors.initials: O
authors.lastname: Mikami
authors.forename: Mikael
authors.initials: M
authors.lastname: von Euler
authors.forename: George
authors.initials: G
authors.lastname: Blackledge
authors.forename: Bob
authors.initials: B
authors.lastname: Milsted
authors.forename: Brent
authors.initials: B
authors.lastname: Vose
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D017277:Drug Approval; D004345:Drug Industry; D019317:Evidence-Based Medicine; D006801:Humans; D017387:Investigational New Drug Application; D007564:Japan; D040541:Marketing / Q000592:standards*; D008495:Medical Oncology; D015337:Multicenter Studies as Topic; D004364:Pharmaceutical Preparations; D011786:Quality Control
chemical_list: D004364:Pharmaceutical Preparations