Biostatistics on the Rise in Japan
Toshimitsu Hamasaki, Scott Evans, and Geert Molenberghs
Japan is second only to the United States as a consumer of pharmaceutical products. This notwithstanding, statistical contributions to clinical trials and clinical development were not well-recognized in Japan until the ICH-E9 guideline “Statistical Principles for Clinical Trials” was implemented in 1998. The guideline helped trigger the revelation that there is a shortage of qualified statisticians who can comprehend and implement the principles outlined in the guideline and improve the integrity of the studies being conducted. At the same time, there were few academic programs to educate and train biostatisticians at Japanese universities. Indeed, in 1998, there was just one biostatistics master’s degree and doctoral program, which was offered by Tokyo University’s Department of Biostatistics. Also, there were only six doctoral-level biostatisticians working in the entire Japanese pharmaceutical industry.
Under the joint leadership of a working group of the Biometric Society of Japan (BSJ) and the statistics and data management working group of the Japanese Pharmaceutical and Manufacturing Association, substantial efforts have been devoted to increasing the number of biostatisticians through the establishment of increased educational opportunities at universities and to developing formal training opportunities for biopharmaceutical statisticians. As a result, five departments have been 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 companies 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 clinical research infrastructure. The plan outlines similar 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.
New training programs also have emerged to meet the needs of the growing biostatistics educational initiatives. One such program is the biostatistics summer school program at Osaka University, organized by Toshimitsu (Toshi) Hamasaki. It was conceived as a four-day training program for graduate students at Osaka University and other local universities, as well as statisticians working in the pharmaceutical industry. Hamasaki noted that these students “are the future of biostatistics in Japan.” This year’s program consisted of two two-day short courses: Longitudinal and Incomplete Data, taught by Geert Molenberghs, and Hot Topics in Clinical Trials, taught by Scott Evans. Molenberghs’ course covered linear mixed models, generalized estimating equations, and missing data in clinical trials. Evans’ course encompassed noninferiority trials, benefit/risk assessment, data-monitoring committees, data monitoring using prediction, subgroup analyses, important issues in clinical trial design, and the growing roles of the biostatistician in clinical trials.
During the short courses, Molenberghs and Evans were struck by the respectfulness and humility of the Japanese students. The instructors were often met with traditional bows and the students were quiet during lectures at first, which caused Molenberghs and Evans to wonder about their comprehension (the lectures were taught in English). However they soon learned this was part of Japanese culture. Questions and discussion during breaks and after the lectures showed the understanding and interest of the students. Molenberghs and Evans enjoyed interacting with the students and discussing issues from the presentations, the future of biostatistics in Japan, and the futures of the students.
Molenberghs and Evans also gave a seminar to the BSJ, an active organization with approximately 500 members. Molenberghs discussed methods for longitudinal data analyses with missing data, while Evans discussed benefit/risk assessment in clinical trials.
The seminar attracted nearly 60 statisticians. Evans also gave a seminar on data monitoring using prediction at the Japanese National Institute of Public Health (NIPH) in Tokyo.
Academic partnerships with Japanese universities have begun to emerge. For example, Kitasato University has established a collaboration with the department of biostatistics at the Harvard School of Public Health (HSPH). Masahiro Takeuchi, chair of the department of biostatistics and pharmaceutical medicine at Kitasato University, is a Harvard alumnus and the recipient of Harvard’s Distinguished Alum Award in 2007. Each year, a Harvard faculty member visits Kitasato University to give a short course or lecture series. This year, Marvin Zelen lectured at the 9th Kitasato-HSPH Symposium, “Advanced and Global Drug Development Techniques: Significance of Asian Studies in Simultaneous Global Clinical Trials.” Another link has been established between Kurume University and the department of epidemiology at the School of Public Health, University of Washington.
It is clear that Japan is increasing its biostatistics quality and quantity. This growth will result in further improvement to an already high level of patient care. For the international community, opportunities for scientific, social, and cultural interactions are manifold. You can view the growth of biostatistics in Japan by attending the XXVI International Biometric Conference (IBC2012), to take place in Kobe, Japan, in August of 2012.