Japan Interchange Points to Increase in CDISC Activities.

AUSTIN, Texas -- The Japan CDISC Coordinating Committee (J3C) held the second annual CDISC Japan Interchange in Tokyo 11-13 July. A government-sponsored research project, independent survey results, and Interchange attendance all indicate that the interest and activities associated with CDISC standards have increased dramatically since last year's J3C event. In addition, it is being recognized in Japan that CDISC standards can make clinical trials more efficient if implemented at the medical institutions where trials are conducted, not only for regulatory submissions.

Yoshio Tsukada of GlaxoSmithKline and Leader of the J3C opened the meeting. "We are very pleased with the interest shown in CDISC in Japan," he said. "There are 80% more attendees at this event compared with the figures from last year. In addition, we have participants from South Korea and India. Representatives are here from the Ministry of Health, Labor and Welfare (MHLW), pharmaceutical companies, academia, laboratories, and technology and service providers."

The first keynote speaker, Dr. Kiuchi of the University Hospital Medical Information Network Center and the University of Tokyo Hospital, reported on Digitalization of Clinical Trials, which is part of an 'Overall Study Report on Clinical Trial Promotion' sponsored by the Japanese government. The research, conducted in Japan and the United States, indicate that CDISC standards are sufficiently mature for implementation and the recommendations were to make database structures compatible with CDISC and encourage software companies to make their tools compliant with the CDISC standards. In addition, the research project acknowledged that the specification development and practical use of CDISC standards has now advanced to a stage where medical institutions in Japan should develop and operate a clinical trial-related information system that is based upon CDISC standards in order to make clinical trials more efficient.

Dr. Furukawa, from the Center for Clinical Trial Management, Kanazawa University Hospital, gave the second keynote, during which he spoke of his annual survey of awareness of CDISC and Health Level Seven (HL7) standards. Since last year, Dr. Furukawa reported, awareness of CDISC by Clinical Research Associates in Japan, albeit still too low, increased from 1% to 10%. Dr. Kimura, Medical Informatics Department, Hamamatsu University School of Medicine and HL7 Japan, presented the third keynote in which he reported on a pilot project to share information within a region of Japan where a variety of electronic health record systems are being used; enabling interoperability among these disparate systems is only possible with the use of standards.

Following the keynotes, there were presentations on CDISC highlights, strategic priorities and technical roadmap by Dr. Rebecca Kush, President, and eight presentations on the CDISC implementation experiences and tools to facilitate implementations. Speakers from Japan, India, UK and US presented. Two days of education on the CDISC standards took place prior to the Interchange, with courses in Japanese and English.

"It is especially encouraging to see Japan embracing the usage of CDISC standards for the sharing of clinical data among researchers during the actual clinical trial process," stated Dr. David Hardison, CDISC Board Chairman and Vice President, SAIC. Although the roots of CDISC standards usage by the US Pharmaceutical companies have been for regulatory submissions, many implementers across the globe are acknowledging, like Japan, that an even greater potential to improve clinical trial efficiencies will be realized by implementing CDISC standards at the beginning of the clinical trial process.

About CDISC

CDISC is an open, multidisciplinary, non-profit organization that has established worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

CDISC is made possible through the generous support of its members, sponsors, and volunteer participants. These include academia, biopharmaceutical companies, technology and service providers, institutional review boards and any organization interested in streamlining biopharmaceutical product development and clinical data quality.

Additional information on CDISC can be found on the CDISC website at www.cdisc.org.