On February 26, the Japanese Health Science Council’s sub-committee on clinical trials set up an FMV pilot program to study clinical trial costs at designated Japanese hospitals. The pilot program will be done in Japan’s fiscal year 2025 which starts in April. This program is to investigate how to keep clinical trial costs at various Japanese hospitals more similar. This program is a result of more multi-national clinical trials being done in Japan, the fact that in the West the FMV paid to each clinical trial site is similar, and the issue that overseas drug companies have difficulties explaining to their overseas global headquarters how different Japanese trial sites have different clinical trial costs. Right now, the Cost Per Case (CPC) at different clinical sites for the same drug trial can vary significantly in Japan.
Up until now, Japan’s National Hospital Organization determines each hospital’s clinical trial expenses via a “point table.” The point table program is only used in Japan, and each site determines its own point value. The Western pharma industry argues that this point system is neither consistent nor transparent and leads to very different cost calculations at each facility. Alternatively, the Western FMV system looks at the clinical trial protocol, sets up similar budgets at each facility, and determines site costs by bench-marking – via market research companies. In this way, the clinical trial costs at each facility become more similar and easier to track.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.