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[V6-S2] Contributions of Statistics and Behavior Observation to Drug and Medical Device Development
Session Chair(s)
Yoichi M. Ito, PhD
Director
Hokkaido University Hospital, Institute of Health Science Innovation, Japan
Recently, big data has been in the news, and a new type of job for statisticians, called data scientists, has been created. However, in the pharmaceutical company, due to the influence of ICH E9, there are many trial statisticians. In other fields, business improvements due to a qualitative method called Behavior Observation are attracting attention. The ease of use of the product is directly linked to it being properly used or not. By the Behavior Observation you can discover needs that even the users weren’t aware of, making it possible to really improve the user friendliness of medical products and devices. At this session, we will look back on the contribution of ICH E9 to the current development of medical products and devices, as well as explore the potential contribution of statistics and behavior observation to the future of medical product and device development.
Speaker(s)
ICH E9 Statistics Guideline: Before & After
Tosiya Shun Sato, PhD
Kyoto University School of Public Health, Japan
Professor, Department of Biostatistics
How Private Sectors Can Generate Value from Statistics
Hiromu Nishiuchi, MS
Data Vehicle, Inc., Japan
Co-founder
Innovation Starts from Deep Understanding of Behavior Contexts - “Behavior Observation” Method, Deriving Potential and Essential Insight
Takafumi Koshino
OGIS-RI Co.,Ltd., Japan
Principal Researcher
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