Page 98 - Contributed Paper Session (CPS) - Volume 7

CPS2040 Makoto Tomita

Summary of bio-statistical consultation for
clinical research support in Japan
Makoto Tomita
School of Data Science, Yokohama City University, Japan.

Abstract
Changes in the environment surrounding recent clinical research are obvious,
and support in the field of statistical analysis is also diverse. We aim to
feedback statistical consulting supported by our center by grasping the
situation and introduce them.

Keywords
Clinical research support; statistical consulting; biostatistics; National
University Hospital; academic research organization (ARO)

1. Introduction
University conducts research in various areas and has the potential of
developing new drugs by nurturing the seeds of research. We will foster
alliance network as an ARO (academic research organization) by sharing
resources and experience that becomes difficult for one member university,
thereby step up as an organization that will contribute to new drug
development. In recent years, evidence-baced medicine (EBM) seems to have
completely established even in the field of clinical research. Evidence in clinical
research means that it is required to be scientifically the most reliable, and
based on that judgment statistical plays a decisive and important role. It
receives about 50 to 80 statistical consultations per year, it tends to increase
with the age and it realizes that it is useful as a biostatistician.
The Ministry of Education, Culture, Sports, Science and Technology's
Ministry of Health, Labor and Welfare established the "ethical guidelines on
research on medical science for human beings" in 2014, the environment
surrounding clinical data became more rigorous, data managers (DM) More
and more, the presence is increasing.
A biostatistics who was assigned to the Center since 2009 has initially
launched a web page of statistical consulting in June and gave a guide in the
hospital by lamppost, etc. The service gradually became widely publicized and
spreading in the word of mouth. I felt as if there were many repeaters from
the same field, I thought that I would like to compile the situation from FY
2010 again and grasp the trend and transition.
Furthermore, at our university, the "Statistical Analysis Support Unit"
targeting clinical researchers at all universities in the Center for Medical

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