What is biostatistics?

Biostatistics is the discipline of statistics as applied to clinical care and health science. Sometimes referred to in Japanese as medical statistics, clinical statistics or ‘baio’ statistics, and in English as medical statistics or biostatistics, is an academic discipline that provides methodology addressing how to efficiently collect, analyze and interpret data with limited resources (subjects, time and cost). In Japan, the education system in this discipline is at an early stage of development, but I will mention the reason for this later. Japanese doctors studying in the US are surprised that large hospitals there always employ biostatisticians to assist with consultations and statistical analysis and practice in clinical and epidemiological research. In Japan, the post of biostatistician has only been created in the last five or six years even in first-grade university hospitals. I graduated from a faculty of engineering and specialized in applied statistics in the field of quality control. Forty years after graduating, my base has not left the University of Tokyo in Hongo, Tokyo. But although it is in the same location, my place of work has changed a great deal from engineering to clinical research in the hospital, and preventive medicine. I shouldn’t say this too loudly, but I spend more and more time doing office work in Ochanomizu where the Japan Clinical Research Support Unit, set up in 2001 to provide support for investigator-initiated clinical and epidemiological research, and the Statcom Company in Ochanomizu, officially recognized by the University of Tokyo as a university launched venture, are located. To summarize my career to date, while aiming to be an applied statistician in the engineering field, I transferred to the field of medical care and health science and was shocked to find there was hardly any education in the biostatistics required for this field in Japan. While creating a basic education system at my university, graduate school and outside the university, I undertook clinical research focusing on the field of cancer as a biostatistician and, more recently, epidemiological research. In my clinical research, I have contributed to the creation of a clinical trial system including data management, CRC (Clinical Research Coordinator) and training medical writers. In recognition of my work, I received the Asahi Cancer Award in September 2014.

Why have there been scandals in clinical trials?

The misconduct in a number of antihypertensive drug clinical trials disclosed in 2013 followed by the STAP cell research scandal have highlighted the fact that the ideas of quality assurance and publishing responsibility are not firmly rooted in our country’s medical research community. Quality assurance in clinical trials means building a clinical trial implementation system and conducting daily quality control so that the data obtained can be trusted and the safety of the participating subjects is ensured. The biostatisticians involved in clinical trials are called trial statisticians, as their role covers not just statistical analysis but also the quality assurance of trials from the design stage through to implementation and final publication. The background to the antihypertensive drug scandals was that no neutral trial statisticians or data centers were involved, the principal investigators supposed to be leading the research had little clinical research experience and failed to understand the concept of quality assurance, and although financial support was provided by pharmaceutical companies in the non-transparent form of scholarship donations, this support was too small and trials could only go ahead with the involvement of company employees in the form of profit-sharing.

In fact, until around 1990 it was perfectly normal for pharmaceutical companies to support doctors’ statistical analyses and document retrieval, and the pharmaceutical companies actually did nearly all the data management, statistical analysis and paper writing in the clinical trials of approved (marketed) drugs. This has been the main reason why there are no statisticians in Japanese hospitals. 1991 saw a revision of the Antimonopoly Act and the creation of its concrete industrial version, the Japan Pharmaceutical Manufacturers’ Association’s Fair Competition Code, followed by the enactment of the Act against Unjustifiable Premiums and Misleading Representations forbidding the provision of free services to healthcare practitioners. The service competition is supposed to have been subsided, but the reality is that it still goes on.

Healthcare and medical care issues and biostatistics

Japanese can receive low cost healthcare services wherever they are thanks to our excellent health insurance system covering whole population, which has resulted in our having the highest average life expectancy in the world. Whether this universal care is sustainable or not is the greatest issue of our time. The causes of this crisis include the aging of our society of course, but also a payment system that increases the income of doctors and hospitals from unnecessary medical treatment, ordinary people’s overdependence on healthcare, insufficient assessment and promotion of effective preventive methods, and the deterioration of lifestyle habits particularly diet and exercise. For example, trial calculations suggest that a 30% reduction in the incidence of diabetes, the leading lifestyle disease, could cover the cost of cancer treatment in Japan. Diabetes patients show a 1.2 to 1.3 times higher risk for cancer than healthy people (equivalent to the risk of exposure to 300 to 500mSv of radiation), and diabetes is the biggest risk factor of retinopathy leading to blindness, artificial dialysis, stroke and dementia. Of course improving lifestyle habits would help to prevent diabetes, but no long-lasting and effective uniform preventive measures have been established. Cancer drug therapy has focused on the development of molecular targeted drugs tailored to the biological character of cancer cells, but in the same way, we also need a PDCA cycle of developing, spreading and assessing preventive measures tailored to people’s lifestyle habits and tastes. The pending My Number system is about to get underway, as is a cancer registry, something that, to our shame, our advanced nation has not had before. Linking individual ID numbers to the “big data” of health insurance and nursing-care insurance databases, hospital databases, and the medication history database (Okusuri Techo) will lead to better prevention and more efficient healthcare and, I believe, to the realization of a sustainably healthy society. The power of biostatistics is needed here, too.

The mission of the Department of Integrated Science and Engineering for Sustainable Society to which I belong is to realize a sustainable society, but my personal mission is to convey a sense of biostatistics and epidemiology to people with the ability to contribute to this aim. Chuo University has many statisticians enrolled and provides a superb environment for learning statistics, and I hope that the students and teachers from other departments and faculties who specialize in statistics, and those who are going to do so, will gain an understanding of the field of biostatistics.

Yasuo Ohashi
Professor, Faculty of Science and Engineering, Chuo University
Area of Specialization: Biostatistics

Professor Ohashi is Emeritus Professor at the University of Tokyo, Chief Director of the Japan Clinical Research Support Unit, Chief Director of the Japan Medical and Scientific Communicators Association, President of the Biometric Society of Japan, Representative Director of the Japan Society of Clinical Trials and Research, Chief Director of CONCIDE (Japan Consortium of Health Information ) and Chairman of Statcom Co., Ltd.

He was born in Fukushima City in 1954. After graduating from the Faculty of Engineering, the University of Tokyo he became an assistant on the same faculty before transferring to the Faculty of Medicine, where he was Lecturer and Assistant Professor at the Department of Central Medical Information from 1984 and Professor at the Department of Epidemiology, School of Health Sciences from 1990. In 1992 he established Japan’s first university course in biostatistics (Department of Epidemiology and Biostatistics ). He resigned from the University of Tokyo in 2014 and took up his current position. In 2001 he set up the Japan Clinical Research Support Unit, which provides support for researcher-led research. He received the 2011 Biometric Society of Japan Award for Outstanding Scientific Contribution and the 2014 Asahi Cancer Award (the first non-doctor recipient).