Updated on 1 September 2015
The trial costs within Japan were calculated based on public data disclosed by local clinical institutions
Singapore: Medidata, a provider of cloud-based solutions for clinical research, has collaborated with Japan Pharmaceutical Manufacturers Association (JPMA) to provide cloud-based technology for streamlining clinical trial costs across Japan by focusing on the consistent budgeting of trial sites.
"As the Japanese clinical trial landscape evolves, it is increasingly important that we ensure consistent and fair payment-both for sponsors and sites," said Mr Shingo Haseto, taskforce leader, clinical evaluation expert committee, JPMA. "We're pleased to be collaborating with Medidata to better understand cost discrepancies and are confident that our research findings will lead to increased transparency around clinical trial costs related to site performance and, in doing so, ultimately improve the drug development process."
Written in Japanese and available to the public, JPMA's report-titled "Research for the optimization of the clinical trial cost paid to investigator sites" highlights the varying cost calculations and payment methods used at different investigative sites in Japan. Further, the analysis compares the differences between these costs and methods to those in countries where clinical trials are regularly conducted, including the United States, the United Kingdom and 17 countries within the Asia-Pacific region. JPMA referenced four sample protocols covering unique therapeutic areas to determine the clinical trial and site costs across a variety of complex trials.
The trial costs within Japan were calculated based on public data disclosed by local clinical institutions. To calculate the clinical trial costs in countries outside of Japan, JPMA leveraged Medidata's comprehensive site budgeting and contract negotiation tool (Medidata Grants Manager).
"Optimizing clinical trial costs will be a critical factor in overcoming current obstacles in Japan's clinical trial landscape," said Mr Takeru Yamamoto, Medidata's managing director of the Asia-Pacific region. "We're pleased that JPMA has selected Medidata's cutting-edge technology for this important research initiative and are committed to streamlining clinical development across Japan to pave the way for future innovative therapies and medicines."