How biostatistics is of rapidly growing importance in Japan

Features

  • Author: Joanna Carpenter
  • Date: 25 Apr 2013
  • Copyright: Image appears courtesy of iStockPhoto

Biostatistics is in good health in Japan, with increasing numbers of Masters-level courses and students, greater internationalization, and improved clinical infrastructure.

Biostatistics has long been recognized as a key component of pharmaceutical, biotechnology, device, and public health research in the US and Europe. Yet, despite a strong pharmaceutical industry, fifteen years ago when the ICH-E9 guideline Statistical Principles for Clinical Trials was implemented, it revealed a biostatisticians’ training system in its infancy.

thumbnail image: How biostatistics is of rapidly growing importance in Japan

Undervalued

The Japanese infrastructure for training and developing biostatisticians was ad hoc. In 1998, there was only one Masters-level programme in the whole of Japan and only six biostatisticians with doctorates working in the pharmaceutical industry. The role of a statistician was limited to using SAS programming skills to analyze data, calculating a sample size or applying likelihood tests and asymptotic theory,

“Typically, statistical education was provided as a part of a broader science or engineering university programme,” explains Toshimitsu Hamasaki, an Associate Professor in the Department of Biomedical Statistics at Osaka University Graduate School of Medicine.

He explains that most people then working in the biopharmaceutical industry were pharmacy graduates, who received on-the-job statistical training.

Professionalizing

“I think there has always been good quality medical statistics and biostatistics research and practice in Japan,” says Geert Molenberghs, Professor of Biostatistics at Hasselt University and KU Leuven in Belgium. As a former President of the International Biometric Society he knows Japanese colleagues well. However, he agrees that there was previously a need for professionalizing the biostatistical component of pharmaceutical development. In Belgium, he says, the Masters programme in biostatistics at Hasselt University was “the driving force for that to happen.”

“Proper, good-level, internationally-rooted, Masters-level training is crucial,” Molenberghs expands.

Masters Training

In response to the ICH-E9 guidelines, the Biometric Society of Japan discussed qualifications for biopharmaceutical statisticians and an academic training programme for statisticians working in the pharmaceutical industry. Numbers of courses and well-qualified biostatisticians subsequently increased.

Professor Scott Evans of Harvard University has been a frequent traveller to Japan over many years. He’s noticed the increase in the number of Masters-level biostatistics courses since 1998.

“By 2009, there were six departments, at Tokyo, Kitasato, Kyoto, Kurume, Osaka, and Toyama. By 2012 there were another five, at Hokkaido, Tohoku, Yokohama City, Doshisha, and Keio. And another will open this April at Nagoya,” he says.

The Japanese pharmaceutical industry now employs many more formally educated Japanese statisticians with Masters degrees or PhDs, and their role has broadened to planning, conducting and reporting clinical trials.

“By 2009, there were six departments, at Tokyo, Kitasato, Kyoto, Kurume, Osaka, and Toyama. By 2012 there were another five, at Hokkaido, Tohoku, Yokohama City, Doshisha, and Keio. And another will open this April at Nagoya” .

Internationally recognized qualifications

Japanese pharmaceutical firms are more interested in Masters graduates with experience than in those with research degrees, Hamasaki says. However, when working internationally as a biostatistical scientist, a higher level of professionalism is required, and a PhD is very useful to show commitment to the profession.

Also relevant internationally is professional accreditation by the American Statistical Association or the UK’s Royal Statistical Society (RSS).

Molenberghs explains, “You can get a qualification based on education, or on proven work experience, or on a combination of both. It’s like a quality stamp, so people – so for example the Masters programme we have in Belgium in our university is accredited by the RSS. That means that people who have a Diploma from the programme can apply to the RSS, be reviewed and easily gain their certification.”

Internationalization

Hamasaki says that most Japanese trainees stay in their home country but some go on to further study abroad, for instance at Harvard or Stanford. “It’s a good opportunity to visit another country. Working with statisticians in other countries is good experience,” Hamasaki says.

Molenberghs agrees. “I think what also is very important is that people travel... it makes you international in a profession that is truly international. Of course there are always national or continental aspects, like the regulatory framework has its specifics in different parts of the world, but the biopharmaceutical industry is truly international and it is important to study abroad or to do an internship of several months or a year, etc, in a company, in an academic institution abroad,” he says.

Hamasaki has noticed an increase in foreigners wanting to come to work or study in Japan, for instance from Korea or China, although numbers are still small.

Another sign of increasing contact with biostatisticians around the world was the success of the International Biometric Conference, held last summer at Kobe, Japan. 585 people attended, including 308 non-Japanese from 41 countries.

The role of regulation

Another driving force for high standards of biostatistics, according to Molenberghs, is the regulatory authorities. “I usually quote three areas in the world that are well organized: the United States, Japan, and Europe,” he says.

Hamasaki has seen improvements in the last few years in how the Japanese regulatory authorities organize things. “Japanese guidance for clinical trials used to require much more documentation – more than other countries,” he says, “but that has now been simplified.”

In addition, he says that the regulator, the Ministry of Health, Labour and Welfare’s (MHLW’s) Pharmaceutical and Medical Devices Agency (PMDA), has increased the number of statisticians it employs from three to ten, and so the time the PMDA takes to review industry applications for clinical trials has reduced.

Data backs this up. “Based on 2004 data regarding new molecular entity (NME) product launches, it took an average of 3.8 years for a drug to be launched in Japan. This is 2.5 years longer than it took in the US. This delayed approval leads to drug lag issues,” says Hamasaki. In 2009, the PMDA set out to shorten the drug review time by two-and-a-half years by 2011, which it achieved, with a median review time of 10.5 months.

..the government has started a new “Five-year clinical trial activation plan” to promote clinical research and trials..

Other signs of health

The clinical research infrastructure was improved by a concerted effort of the Japanese government in its five-year plan from 2006-2011. Academic institutes and national disease centres opened data coordinating centres in hospitals, with staff including statisticians and data managers. Clinical Research Coordinators received training and standards of trials for new drugs applications improved.

In addition, the government has started a new “Five-year clinical trial activation plan” to promote clinical research and trials. The plan also calls for a study on incentives for companies and researchers to encourage clinical trials in difficult areas such as pediatric diseases and rare, refractory diseases with small numbers of patients.

A sign of the growing importance of Japan in biostatistics is perhaps shown by the plans of others. “The Frontier Science and Technology Research Foundation, a not-for-profit organization specializing in biostatistical science and data management, has plans to open a new office in Tokyo,” Evans says.

In growing mode

As well as highlighting the contribution of the pharmaceutical industry and the authorities to the growth of biostatistics in Japan, Evans says there are more personal reasons. “A major reason for the growth is people like Toshi [Hamasaki] demonstrating the value of statistical thinking to medical colleagues, being proactive at building an educational foundation for statistical science in Japan, and promoting international collaborations to enhance education,” he says.

Hamasaki has organized an annual Biostatistics Summer School at Osaka since 2007, at which both Evans and Molenberghs have taught. It is part of a continuing education programme for statisticians working in pharmaceutical sector to maintain, improve and broaden their knowledge and skills. It also aims to help them develop the required personal qualities. Most of those attending have Masters degrees or doctorates with three to five years' experience in the pharmaceutical industry or academia.

Every year, two distinguished speakers give separate short courses at the Summer School. In the last few years, as well as Evans and Molenberghs, these have included Frank Bretz (Novartis), Alex Dmitrienko (Quintiles), Andy Grieves (Aptiv Solutions/King's College), James Hung (US-FDA), Tatsuki Koyama (Vanderbilt University), Naitee Ting (Boehringer Ingelheim), Sue-Jane Wang (US-FDA), Geuosheng Yin (University of Hong Kong/MD Anderson Cancer Center).

However, the work is not entirely over, yet. “Training in biostatistics and medical statistics-related fields could shift to a higher gear and involve more international faculty, as is done in many parts of the world,” says Molenberghs.

Evans highlights that this is beginning to happen. He holds a visiting position at Osaka University, which he visits every two years to teach an Introduction to Clinical Trials course to medics, and he has a strong working relationship with Hamasaki. In addition, he says, the statistics departments at Harvard and Kitasato University in Japan have an ongoing collaboration.

It looks as though the infant is fast entering adolescence.

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