[Multi-national clinical trial in circulatory disorders].
As Japan becomes more integrated into the global market, pharmaceutical research and development (R&D) in Japan faces considerable challenges. While global simultaneous development including Asian countries has become a common strategy for multi-national pharmaceutical companies, Japan has been frequently set aside because of its provincial regulatory and clinical trial infrastructure. Meanwhile, many improvement programs in pharmaceutical area have been initiated in Japan. With this increased scrutiny, significant improvements in regulatory process, clinical trial costs, and site performance are anticipated over the next few years. RENAAL is the first multi-national clinical trial involving Japanese patients diabetic nephropathy associated with type II diabetes mellitus. In this article, issues which have been observed in the process of conducting multi-national clinical trial were discussed based on the experience with RENAAL. It is hoped that, as we gain more experiences in multi-national clinical trials, solutions for these issues are found in near future.
Takahashi
Kihito
K
Banyu Pharmaceutical Co., Ltd, Tokyo, Japan. kihito_takahashi@merck.com
D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003928:Diabetic Nephropathies / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D006801:Humans; D007391:International Cooperation; D007564:Japan; D019808:Losartan / Q000627:therapeutic use; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic
D047228:Angiotensin II Type 1 Receptor Blockers; D019808:Losartan