[Globalization of clinical trials].
Based on reviews of the Japanese clinical trial situation in lung cancer, gastric cancer, prostate cancer and breast cancer, it was clear that much progress has been made in short time. There are considerable differences between Japan and the West and also differences between clinical areas in Japan. For regulatory purposes bridging studies have become increasingly important. Use of identical protocols are required for effective bridging. Participations in global phase III trials is the best way of achieving registration in Japan. For successful global trials in Japan it is important to include Japanese investigators in the preparation of the protocol and to recognise the challenges facing such a project. Clinical practice in diagnosis and treatment have many differences, thus it is recommended to have clear and detailed information in the protocol. Hard end points like survival are important since they are not biased by cultural differences. There are clear difficulties with HE or QOL outcomes. The emergence of focus on evidence based medicine is also happening in Japan and will help to harmonize documentation across the world. For large adjuvant or prevention cancer global trials are essential. To facilitate global studies further development of infrastructure is necessary in Japan. Use of electronic data capture web based communication etc. will help overcome communication difficulties. Other improvements that will make Japanese participation in global trials easier and better include establishment of clinical trial centre at each hospital, introduction of trial coordinators or study nurses and an improved collaboration with company staff. A critical issue that also need addressing is agreement of centre target recruitment. We need to introduce a new flexible system in Japan if participation in global trial is to be optimised. If we can address these issues Japanese investigators and collaborative groups should be able to initiate and lead global trials in the future.
Akaza
Hideyuki
H
Dept. of Urology, Institute of Clinical Medicine, University of Tsukuba.
Fukuoka
Masahiro
M
Ohtsu
Atsushi
A
Usami
Michiyuki
M
Ikeda
Tadashi
T
Aiba
Keisuke
K
Isonishi
Seiji
S
Ohashi
Yasuo
Y
Saijo
Nagahiro
N
Sone
Saburo
S
Tsukagoshi
Shigeru
S
Tsuruo
Takashi
T
Kato
Masuhiro
M
Mikami
Osamu
O
Dong
Rui-Ping
RP
von Euler
Mikael
M
Blackledge
George
G
Stribling
Don
D
D000970:Antineoplastic Agents; D002986:Clinical Trials as Topic / Q000592:standards* / Q000639:trends*; D003142:Communication; D017277:Drug Approval; D004345:Drug Industry; D006801:Humans; D017387:Investigational New Drug Application; D007564:Japan; D008495:Medical Oncology / Q000639:trends; D009369:Neoplasms / Q000628:therapy*
D000970:Antineoplastic Agents