CDISC Blog

The Growing Role of Academia in Japan - March 2012 Organized by Translational Research Informatics Center (TRI)

On behalf of Dr. Fukushima, the director of the Translational Research Informatics Center (TRI), Kobe, Japan, Dr. Rebecca Kush was invited to be a keynote speaker at the final session of a meeting that took place on 2-3 March 2012 in Tokyo; the theme was Life Science Innovation: The Growing Role of Academia in Japan. This final session was entitled “Coordination, Support and Training Program for Translational Research” and was slated as “one of the most important national projects of the Japanese Ministry of Education, Culture, Sports, Science and Technology (MEXT)”.

TRI and MEXT developed this program over the course of 5 years to increase the application of basic research to patient care, so called Translational Research, through promoting organizations, within universities to become centers of translational research. Moreover, as a part of the program, TRI has also been working on projects in relation to CDISC standards and has translated CDISC standards into Japanese.

The requested presentation title for Dr. Kush was “Current Status and Future Scope of CDISC standards”. Dr. Kiyoteru Takenouchi (CMIC and Director on the CDISC Board) chaired the session. The other presentation in this session was provided by Ms. Jono of TRI, who spoke about myths around the use of CDISC standards (e.g. that they are only for FDA submissions) and about CDISC-Compliant EDC (eClinicalBase), which is an application TRI has developed and implemented for clinical studies done by TRI. eClinicalBase makes use of CDISC standards to streamline the entire clinical study process.

Dr. Kush spoke about the CDISC Strategic Goals for 2012-2015 and important collaborations that are enabling this work. TRI represents a key CDISC collaboration. In addition to streamlining their own processes using CDISC standards, they are: a) providing the CDISC standards in Japanese via the CDISC members area to attract more Japanese member organizations; b) implementing the Alzheimer’s Disease standard in a study being conducted in Japan and China; c) publishing articles on CDISC in a well-read journal for which Dr. Fukushima is editor; and d) strongly encouraging the use of CDISC standards among the universities that receive funding from TRI.

Closing comments by Dr. Nagai and Dr. Fukushima included concern that Japan needs to continue to strive towards the use of EHRs for research in the future and that this final session (which also included a presentation by a Seattle-based statistician specializing in cancer treatment statistics) represents the next step in this important MEXT program – globalization.