It is printed in the A4 size.To the laboratory site

 - Clinical Medicine (Core Departments)
Clinical Trial Design and Management
Translational Research Center
Clinical trials are defined as intervention studies on human beings that designed to test the hypothesis for diagnostic techniques, treatments, and disease preventions. Any novel medical technologies should be evaluated the efficacy and safety by clinical trials. Our department is the first research branch in Japan to study and educate on clinical trial design, management, statistical analysis, and assessment, which covers from the development of new treatments to establishing of standard therapy.

Research and Education
Our department aims at “to improve treatment outcomes for intractable diseases” and assists in running investigator-sponsored clinical studies ( At the study planning and protocol development phase, we objectively assess ethical and scientific appropriateness, and feasibility of study. At the implementation phase, we carry out the data management, monitoring, and statistical analysis that is fundamental to the quality control of study, independently with the sponsor and the investigators. The staff members consist of medical doctors, biostatisticians, data managers, monitors, IT specialists, data analysts. For the projects in Translational Research Center of Kyoto University Hospital, we support protocol developments as members of protocol committee, and conduct the data management including CRF (case report forms) designing, database designing, patient enrollment and allocation, data entry and data review. We also perform the monitoring including SDV (source data verification) and safety monitoring, and the statistical analysis including study designing, randomization and data analysis. Since to know state-of-the-art for treatment outcomes is most important for designing clinical trials, we carry out lots of outcomes research in collaboration with medical departments.

Clinical Trial Design and Management
Translational Research Center

Satoshi Teramukai

Harue Tada,
Mariko Doi,
Kenichi Yoshimura
TEL +81-75-751-3858
FAX +81-75-751-4732
Medical science, health care and technology assessment
Prognostic index for ovarian cancer: PIEPOC
This is a framework of Bayesian approach.
Prior distribution and data are combined by Bayes’s theorem for creating posterior distribution.
We can also predict the future using the predictive distribution.
Recent Publications
1. Tanaka S, Kinjo Y, Kataoka Y, Yoshimura K, Teramukai S. Statistical issues and recommendations for non-inferiority trials in oncology : A systematic review. Clin Cancer Res 2012 ;18 :1837-1847.
2. Zhou B, Zhao Q, Teramukai S, Ding D, Guo Q, Fukushima M, Hong Z. Executive function predicts survival in Alzheimer disease: A study in Shanghai. J Alzheimers Dis 2010;22:673-682.
3. Teramukai S, Kitano T, Kishida Y, et al. Pretreatment neutrophil count as an independent prognostic factor in advanced non-small-cell lung cancer: An analysis of Japan Multinational Trial Organisation LC00-03. Eur J Cancer 2009;45: 1950-1958.
4. Kishida Y, Kawahara M, Teramukai S, et al. Chemotherapy-induced neutropenia as a prognostic factor in advanced non-small-cell lung cancer: Results from Japan Multinational Trial Organization LC00-03. Br J Cancer 2009;101: 1537-1542.
5. Zohar S, Teramukai S, Zhou Y. Bayesian design and conduct of phase II single-arm clinical trials with binary outcomes: A tutorial. Contemp Clin Trials 2008;29: 608-616.
6. Teramukai S, Ochiai K, Tada H, Fukushima M. PIEPOC: A new prognostic index for advanced epithelial ovarian cancer – Japan Multinational Trial Organization OC01-01. J Clin Oncol 2007;25: 3302-3306.
7. Teramukai S, Nishiyama H, Matsui Y, Ogawa O, Fukushima M. Evaluation for surrogacy of end points by using data from observational studies: Tumor downstaging for evaluating neoadjuvant chemotherapy in invasive bladder cancer. Clin Cancer Res 2006;12: 139-143.