August 25, 2006

Clinical research training program heads to Japan

Featured Image

Faculty members who travel to Japan to teach in an innovative new clinical research training program are, from left, Ayumi Shintani, Ph.D., M.P.H., Yu Shyr, Ph.D., Paul Harris, Ph.D., and Daniel Byrne, M.S.
Photo by Susan Urmy

Clinical research training program heads to Japan

Daniel Byrne, M.S., carries around a textbook he wrote but cannot read.

That's because it's been translated into Japanese.

Last year Byrne and three other faculty members from Vanderbilt University School of Medicine's innovative clinical research training program were asked to help establish a similar program in Japan.

Once a year, for two weeks at a time, they take turns teaching courses in biostatistics, data management, medical writing and clinical trials at Tokai University School of Medicine in Isehara, about 30 miles south of Tokyo.

The two-year-long program, which grants a Master of Science degree in Clinical Biomedical Science, is modeled on Vanderbilt's highly regarded MSCI (Master of Science in Clinical Investigation) program, and is the first of its kind in Japan.

In addition to Byrne, senior associate in Biostatistics and director of Biostatistics and Study Design for Vanderbilt's General Clinical Research Center (GCRC), faculty members who teach in Japan include:

• Paul A. Harris, Ph.D., research associate professor of Biomedical Informatics and Biomedical Engineering, and director of the GCRC Informatics Core;

• Ayumi Shintani, Ph.D., M.P.H., research assistant professor of Biostatistics and Medicine; and

• Yu Shyr, Ph.D., Ingram Professor of Cancer Research, and professor of Biostatistics and Preventive Medicine.

The Japanese program is the brainchild of an MSCI graduate, Hiroyuki Kobayashi, M.D., Ph.D., professor of Clinical Pharmacology at Tokai University School of Medicine and director of the recently established GCRC at Tokai University.

“He noticed that people in Japan were very willing to do clinical research, but they did not have a well structured system,” said Talat “Alp” Ikizler, M.D., associate professor of Medicine who directs the Vanderbilt MSCI program.

“They didn't have a GCRC,” Ikizler said. “That's one of the strengths of our program. You have those exposures: how to do studies in the GCRC … (and) how to set up a project.”

Kobayashi was introduced to the Vanderbilt program through Iekuni Ichikawa, M.D., a former vice dean of Tokai University School of Medicine. Ichikawa, who also is a former director of the Division of Pediatric Nephrology at Vanderbilt, still holds professorships here in Pediatrics and Medicine.

Through Ichikawa, Kobayashi learned about Vanderbilt's GCRC, which consistently ranks among the top in the country in research productivity.

He also learned about the MSCI program, which trains investigators in the techniques and processes of patient-oriented research.

The program, which this summer graduated its sixth class, was started in 1999 by Nancy J. Brown, M.D., and the late Thomas A. Hazinski, M.D., with initial support from the National Institutes of Health.

Japan's embracing of the program “is a real tribute to the quality of the teachers that we have here,” said Brown, professor of Pharmacology, who this summer was named associate dean for Clinical and Translational Scientist Development.

Vanderbilt's MSCI program is open to board-eligible physicians currently enrolled in fellowship programs; faculty members with the consent of their department chairs; post-doctoral Ph.D. scientists seeking careers in patient-oriented research; and Ph.D. candidates in the Vanderbilt School of Nursing.

It has three components: didactic instruction in subjects ranging from biostatistics and biomedical ethics to clinical pharmacology and new methodologies such as proteomics; career development seminars in such areas as grant management and scientific communication; and mentored clinical research.

With support from the Japanese government, Kobayashi has established his country's first systematic clinical research training program at Tokai University.

The second MSCI class will begin studies there this fall.

Byrne admitted that it's a bit unnerving to teach from the translated version of his 1998 textbook, Publishing Your Medical Research Paper, since he doesn't read or speak Japanese.

The program is quickly training Japanese faculty members to take over the teaching duties, however, and the Japanese government is funding the establishment of clinical research training programs at three other universities.

“The educational component is priceless,” said Ikizler, a native of Turkey who is also the medical director of the Outpatient Dialysis Unit. “To be able to have somebody teach you how to write a grant, how to write a manuscript … one cannot imagine how much time you save.

“The students in the MSCI program learn more (in two years) than I did in 14 years of clinical research experience,” he added. “I learn from them. This is a phenomenal resource.”