CDISC and Japan Agency for Medical Research and Development Partner to Train Leading Academic Researchers

CDISC and Japan Agency for Medical Research and Development Partner to Train Leading Academic Researchers

Austin, TX – 15 June 2020 – CDISC has entered into a partnership with the Japan Agency for Medical Research and Development (AMED) to train leading academic researchers in Japan on standardizing data using CDISC standards.

Under the partnership, academic researchers will receive training via CDISC’s online educational applications. Once trained, researchers will provide feedback to CDISC so data standards teams can then incorporate learnings into new versions of the standards as well as into future tools and trainings. The goal of the project is to understand the needs of Japanese academic researchers so that CDISC can create and maintain the implementation resources necessary that will encourage academic researchers to standardize data, thus promoting and advancing clinical research as well as medical product collaboration and development.

“We are delighted to work with AMED on this important initiative,” commented David R. Bobbitt, CDISC President and CEO. “This historic partnership will ensure that investments by AMED into critical research will eventually lead to standardized data. There is a significant unmet need globally among academic researchers for useful data standards, particularly tools and guidance to lower the threshold for academics to utilize mature data standards. I believe AMED is taking the right approach to this opportunity, and CDISC is proud to partner with AMED.”

Established in 2015, AMED is a Japanese funding agency that promotes integrated research and development in the field of medicine, from basic research to clinical trials, with a strong emphasis on the development of new approaches to diagnostics and therapeutics, fast-tracking medical research and development. AMED has been gathering information on CDISC standards and seeking ideas to familiarize Japanese academic researchers involved in clinical development in the use and understanding of CDISC standards.

“I am delighted to succeed from the past president Dr Suematsu, the new partnership with CDISC,” stated Dr. Yoshinao Mishima, the newly appointed president of AMED as of April 2020. “While the focus of AMED is on developing new therapeutic and diagnostic approaches in medicine, we also put emphasis on the importance of data sharing and implementation of such policies as a vital approach to fast-tracking development in medicine. I hope our new partnership will enable Japanese academic researchers to familiarize themselves with data standardization using globally established standards such as CDISC.”

Since 2012, the community of CDISC users in Japan has grown significantly as members of the Japan CDISC Coordinating Council (J3C) promote awareness and support the implementation of CDISC standards.   

CDISC creates clarity in clinical research by convening a global community to develop and advance data standards of the highest quality. Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the China National Medical Products Administration (NMPA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. With the help of CDISC standards, the entire research community can maximize the value of data for more efficient and meaningful research that has invaluable impact on global health. CDISC is a 501(c)(3) global nonprofit charitable organization and is headquartered in Austin, Texas, with hundreds of employees, volunteers, and member organizations around the world.

Ann P. White