Medidata, a global provider of cloud-based solutions for clinical research in life sciences, has announced a research collaboration with the Japan Pharmaceutical Manufacturers Association (JPMA), a nonprofit organization dedicated to developing innovative pharmaceuticals to improve the health and welfare of people worldwide.
JPMA's research initiative—which leveraged Medidata’s cloud-based technology and proprietary database of industry benchmark costs—underscores the importance of 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 Shingo Haseto, taskforce leader, Clinical Evaluation Expert Committee at 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.”
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 U.S., the U.K. 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). Harnessing Medidata's PICAS database of negotiated investigator grants—which contains information from more than 241 sponsors, more than 326,000 investigator contracts and 29,900 protocols in over 1,900 indications—Grants Manager leverages industry benchmarks to ensure appropriate payment and expedited site contract agreements.
“Optimizing clinical trial costs will be a critical factor in overcoming current obstacles in Japan’s clinical trial landscape,” said 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.”