One of the few departments of biostatistics in Japan
Fostering researchers who bridge the gap between
clinical practice and research and ensure the quality of research.

医学統計学分野 教授
Biostatistics Professor
山口 拓洋
Yamaguchi Takuhiro

山口 拓洋


Providing methods of statistical analysis and planning of investigations and experiments in medical research


医学統計学とは、基礎・臨床・疫学といった医学研究において、 どうデータを取るか(調査計画・実験計画)、どう解析するか(統計解析)の方法論を提供する応用学問であり、日本では医学研究に関わる統計家の数が欧米と比べて極端に少なく、本分野は医学統計学が学べる数少ない教室の一つです。研究テーマは、医学研究(臨床研究、疫学研究など)デザインの開発と評価、医学データに対する統計解析手法の開発と評価、医学研究の品質マネジメントに関する研究および医学データベースの利用に関する研究を中心に、薬剤疫学研究等を含むレギュラトリーサイエンス研究などから成り立っています。医学系研究科公衆衛生学専攻情報健康医学講座に属するとともに、臨床研究を支援する研究者(臨床研究コーディネーター、データマネジャー、医学情報専門家、薬事専門家など)を育成する高度臨床研究支援・管理者育成コースの運営と教育にも関わっています。また、大学院での講義や研究コンサルティングなどを通じて学内外の研究者への教育に従事しています。さらに、東北大学病院臨床研究推進センターおよび臨床試験データセンターと連携し、実際の臨床現場で生じるいろいろな問題について統計学・情報管理学的な観点から関与し、さまざまな共同研究を行っています。

●Please give us an overview of research in your laboratory.

Biostatistics is an applied science providing methodology of how to obtain data (i.e., planning of investigations and experiments) and how to analyze them (i.e., statistical analysis). In Japan, the number of statisticians involved in medical research is extremely few compared with those in Europe and America, and our department is one of the few biostatistics department in Japan. Research topics include the following: development and evaluation of designs of medical research (i.e., clinical and epidemiological research) and statistical analysis methods; quality management of medical research; utilization of medical database; regulatory science research including pharmacoepidemiological studies. Our department belongs to School of Public Health, Graduate School of Medicine and is also involved in the education and operation of the Advanced Clinical Research Support and Management Training Course which develops researchers who support clinical research e.g., clinical research coordinators, data managers, medical information specialists, and pharmaceutical experts. In addition, we are educating researchers from inside and outside the university by giving lectures in the Graduate School and by providing research consulting services. Furthermore, we are conducting cooperative research with Clinical Research, Innovation and Education Center (CRIETO), and Clinical Research Data Center in Tohoku University Hospital and advise them on various problems that occur in the actual clinical practice from the perspectives of statistics and information management.


Studying in a harmonious atmosphere and bridging the gap between clinical practice and research



●What is the atmosphere like in your laboratory?

Many students in our laboratory are also working, thus, it is usually relaxing. It is harmonious during the seminar.



●Please give the students who want to enter graduate school a message including your expectations for them.

When we conduct the research, it is necessary that various experts should get involved and cooperate with one another to ensure its quality. Coordination is an important role for research specialists such as statisticians. Would you like to bridge the gap between clinical practice and research?


Graduates work in pharmaceutical companies and the organizations supporting the clinical research



●What are the career paths of the graduates of your laboratory?

They commonly work as research specialists such as statisticians and data managers in pharmaceutical companies and the organizations supporting the clinical research.



●Is it possible to study in your laboratory while working at the hospital or the company?

Yes, of course, it is possible.


Engaging in the event to raise awareness of childhood cancer, AYA cancer, and clinical trials



●What is the good point of Tohoku University?

I think it is the environment that allows conducting free research.



We are engaged in the activities to raise awareness of problems of pediatric cancer, AYA cancer, and clinical trials for treatment development in collaboration with various stakeholders based on entertainment.


医学統計学分野 教授
Biostatistics Professor
山口 拓洋
Yamaguchi Takuhiro

東京大学博士課程を中退、本邦初の生物統計担当審査官として、現PMDAで研さんを積む。東京大学生物統計学講座、EORTCデータセンター、東京大学臨床試験データ管理学講座を経て、現在、東北大学大学院医学系研究科医学統計学分野教授、東北大学病院臨床試験データセンター長。JCOG外部委員、J-SUPPORT執行委員、厚労省薬事・食品衛生審議会委員、PMDA専門委員などを歴任。所属学会は、日本臨床試験学会(代表理事)、日本計量生物学会(評議員)、日本薬剤疫学会(理事)、日本臨床腫瘍薬学会(理事)など。日本計量生物学会 責任試験統計家、日本薬剤疫学会 認定薬剤疫学家。専門は生物統計学、薬剤疫学、アウトカム研究を含む臨床研究方法論、Entertainment-based Medicine。

Leaving the PhD program at the University of Tokyo, he started his career at the PMDA as the first biostatistical reviewer for new drug applications in Japan. He worked at the Department of Biostatistics, Graduate School of Medicine, The University of Tokyo, EORTC data center, Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo. Currently, he is a professor of the Division of Biostatistics, Tohoku University Graduate School of Medicine, and the director of the Clinical Research Data Center in Tohoku University Hospital. He has worked as an external committee of JCOG, an executive committee of J-SUPPORT, a committee of Pharmaceutical Affairs and Food Sanitation Council of the Ministry of Health, Labour and Welfare, and an expert advisor of PMDA. He belongs to several academic societies including the Japan Society of Clinical Trials and Research (as a representative director), The Biometric Society of Japan (as a councilor), Japanese Society for Pharmacoepidemiology (as a director), Japanese Society of Pharmaceutical Oncology (as a director). He is qualified as a responsible trial statistician of The Biometric Society of Japan, and as a certified pharmacoepidemiologist of the Japanese Society for Pharmacoepidemiology. His majors are biostatistics, pharmacoepidemiology, clinical research methodology including clinical outcomes study, and Entertainment-based Medicine.


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