"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."
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®). Harnessing Medidata's PICAS® database of negotiated investigator grants—which contains information from over 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."
About Japan Pharmaceutical Manufacturers Association
The Japan Pharmaceutical Manufacturers Association (JPMA) is an organization of research and development (R&D) oriented pharmaceutical manufacturers (72 companies). We strive to make contributions to improve the health and welfare of the peoples of Japan and the world through the development of innovative pharmaceutical products and sound advancement of the pharmaceutical industry.
Medidata is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. The Medidata Clinical Cloud® brings new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting. We are committed to advancing the competitive and scientific goals of global customers, which include over 90% of the top 25 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations.
About Grants Manager
Medidata Grants Manager® is the site budgeting and contract negotiation suite that ensures appropriate payment and expedited site contract agreements. Harnessing actual negotiated grants and industry benchmarks from Medidata's proprietary PICAS® database—the industry's largest database of negotiated procedure costs—the tool allows users to analyze their company's specific grant history to build more accurate budgets. Grants Manager is the only budgeting product on the market that shows protocol complexity, procedure frequency and site-specific costs so sponsors can pay appropriate salaries and improve their negotiation strategy. Additionally, Grants Manager enables users to take action by facilitating payment setup and plugging into the Medidata Clinical Cloud platform, providing access to upstream data for faster budget development and downstream data for better study execution.