CDISC Blog

At 23:00 Japan time on Thursday, 10 November, after traveling for ~ 22 hours (starting from JFK in New York City) I arrived at the Seahawk Hilton in Fukuoka, Kyushu. I made an effort to get some sleep that night since my presentation was scheduled for 17:00 on Friday, 11 November at Kyushu University. It was an interesting feeling to return to Kyushu ~ 25 years after I had given a presentation there on an entirely different subject when I was living and working in Tokyo…before CDISC was even a dream. This area has experienced significant growth, yet it is still beautiful with its seaside location and nearby mountains and pine trees. The next morning I realized I was right on the water, at the tip of Japan and only about an hour from Korea by boat.

Dr. Ken Toyoda had been inviting me to speak in Kyushu for several years now, so the Kyoto QA Conference (see previous blog) offered an opportunity to do so on the prior Friday. Approximately 40 doctors, dentists and researchers, most in white coats, were in attendance for the presentation on CDISC. Dr. Toyoda leads the ISO TC215 group in Japan and I know him from ISO meetings; he also launched a Clinical Research support organization/CRO and works with the Center for Clinical and Translational Research at Kyushu University. He and Junji Kishimoto, who created an English business card especially for my visit, provided translations and comments at various points throughout the lecture. I could not resist but begin my presentation with a slide showing only 11-11-11. That was the current date and the only day of this year when metadata was not essential to interpret the date!

During the presentation, Yoichi Nakanishi, MD, PhD, Professor and Director of the Research Institute for Diseases of the Chest in the Graduate School of Medical Sciences at Kyushu University, asked excellent questions about controlled terminology and other relevant topics. He is an opinion leader in lung cancer who spent time at the US NIH/NCI in previous years. Afterwards, Drs. Toyoda, Nakanishi and Kishimoto, along with Dr. Tokunaga and Dr. Uchiyama, from Kyushu University Medical Information Center and Clinical and Translational Research Center (respectively) as well as a representative of the Ministry of Health, Labour and Welfare (MHLW) were very kind to spend their Friday evening sharing stories and delicious Japanese food with me and my colleague, Kiyoteru Takenouchi who is a member of the J3C and the CDISC Board (Dr. Takenouchi received his PhD from Kyushu University). The folks at Kyushu University are becoming interested in CDISC standards as they do medical research; they are anxious to see progress in the therapeutic area standards, especially oncology.

Saturday morning, 12 November, Dr. Takenouchi (Kiyo) and I went to the train station with plans to take the Shinkansen to Kyoto. We were met with an extremely rare occurrence in Japan – the Shinkansen was stopped. Hence, we ended up flying to Osaka and taking a taxi to Kyoto. Unfortunately, we were nearly 2 hours late for our luncheon with 6 individuals from the Translational Research Informatics (TRI) Center, who came from Kobe to meet with us. Although we missed the lovely luncheon, at least we still had an hour to talk. The session was recorded and will be written into an article for an established journal in Japan, specifically the Journal of Clinical Evaluation. Dr. Fukushima, the head of the TRI Center, is very well-respected and is the head of the editorial board for this journal; he has planned for a set of articles about CDISC to be published. He informed me that the TRI Center, which is funded by the Japanese government, has provided grants to a number of Universities. They are strongly encouraging those Universities to use CDISC standards; he feels this is essential to streamlining research and decreasing the associated costs. The TRI Center has many protocols running (and would like to see an ‘implementable’ version of the CDISC PR model). They are using the Alzheimer’s disease standard in a study soon to be initiated in Japan and China. This work was capably presented by Dr. Nagai at the CDISC Interchange in October 2011 in Baltimore. CDISC has an MOU with the TRI Center, which is translating the CDISC glossary and standards into Japanese to increase their adoption in Japan. They are also encouraging organizations, including academic institutions in Japan, to join CDISC. Ms. Takako Jyouno (who took the photo) is interested in becoming an authorized CDISC instructor for academic institutions in Japan. Ms. Yamada, who met with us in Baltimore and developed the MOU was unable to join us this time. Dr. Fukushima and his group (see below for those who were in Kyoto on 12 November plus Ms. Jyuono) are to be commended for their fine example and excellent work in science and translational research in Japan and beyond.

After the Kyushu and Kyoto activities, including the 3rd Global QA Conference Sunday, there was a Legacy Data Conversion Workshop in Tokyo sponsored by the J3C. Peter Van Reusel of Business and Decision in Brussels led the Workshop and stayed on to teach an SDTM course for the following 2 days. Peter set a trend at dinner – red wine with shabu shabu….before I knew it, nearly all of the J3C members were trying that out (in addition to the traditional beer and sake)!

Another ‘blast from the past’ for me was that the location of the Workshop was at Eisai Co. Ltd. Yes, we were in a lovely new building (the Koishikawa Knowledge Center), but right across the street was the building where I worked when I lived in Tokyo ~ 25 years ago. Many thanks to our J3C friends for hosting and organizing this CDISC event, which was a ‘replacement’ for the Interchange that they had to cancel due to their national disasters last year. We wish them well in their recovery and look forward to their coming Interchange in July 2012, when they will celebrate 10 years at a CDISC Coordinating Committee!

Many thanks to our J3C friends for hosting and organizing this CDISC event, which was a ‘replacement’ for the Interchange that they had to cancel due to their national disasters last year. We wish them well in their recovery and look forward to their coming Interchange in July 2012, when they will celebrate 10 years at a CDISC Coordinating Committee!