INTERNATIONAL
Biostatistics on the Rise in Japan
Toshimitsu Hamasaki, scott evans, and Geert molenberghs
J
apan is second only to the United States as a Table 1—Departments Providing master’s and Doctoral
consumer of pharmaceutical products. This Programs in Biostatistics in Japan
notwithstanding, statistical contributions to
clinical trials and clinical development were not
Department Responsible Established
well-recognized in Japan until the ICH-E9 guide-
Person
line “Statistical Principles for Clinical Trials” was
implemented in 1998. The guideline helped trigger
Department of Yasuo 1992
Biostatistics, School Ohashi
the revelation that there is a shortage of qualified
of Public Health,
statisticians who can comprehend and implement University of Tokyo
the principles outlined in the guideline and improve
Department of Masahiro 1999
the integrity of the studies being conducted. At the
Biostatistics and Takeuchi
same time, there were few academic programs to Pharmaceutical
educate and train biostatisticians at Japanese uni-
Medicine, School of
versities. Indeed, in 1998, there was just one biosta-
Pharmacy, Kitasato
University
tistics master’s degree and doctoral program, which
was offered by Tokyo University’s Department of
Department of T. Shun Sato 2000
Biostatistics. Also, there were only six doctoral-level
Biostatistics, Kyoto
University School of
biostatisticians working in the entire Japanese phar-
Public Health
maceutical industry.
Biostatistics Center, Tatsuyuki 2004
Under the joint leadership of a working group
School of Medicine, Kakuma
of the Biometric Society of Japan (BSJ) and the
Kurume University
statistics and data management working group of
Department of Toshimitsu 2004
the Japanese Pharmaceutical and Manufacturing
Biomedical Statistics, Hamasaki
Association, substantial efforts have been devoted
Osaka University
to increasing the number of biostatisticians through School of Medicine
the establishment of increased educational oppor-
Division of Biostatistics Hideki 2008
tunities at universities and to developing formal and Clinical Origasa
training opportunities for biopharmaceutical stat-
Epidemiology,
isticians. As a result, five departments have been
University of Toyama
School of Medicine
established (see Table 1).
Still, the Tokyo University of Science program
was closed in 2008. The program was supported by
several global and domestic pharmaceutical compa-
nies and established with a time limit of five years.
Its purpose was to develop qualified statisticians in
the short term, which it did (see Figure 1).
Most new graduates started their careers as
biostatisticians in the biopharmaceutical sector.
Although the changes over the last decade are great,
the Japanese government is continuing to address
the needs via a five-year plan for improving the clin-
ical research infrastructure. The plan outlines simi-
lar increases in the number of data managers and
clinical research coordinators, as current numbers
in Japan are still relatively small when compared to
the United States and Europe.
Figure 1. Numbers of new graduates from programs at
the Tokyo university of science, Kurume university, and
Kyoto university
NOVEMBER 2009 AmstAt News 25
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