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[S17] Sharing Individual Participant Data (IPD) from Clinical Trials and Personal Information Protection
Session Chair(s)
Tomoko Kato
Head of Biostatistics & Programming, R&D
Sanofi K.K., Japan
Sharing IPD from clinical trials is being promoted to ensure transparency in clinical trials and to improve public health. At the same time, data providers are challenged to safeguard participant privacy in compliance with data privacy legal requirements, and some data users are concerned that anonymized data will provide less utility. This session will discuss both the challenges and benefits of promoting the sharing of IPD such as, for example, a mechanism by which pharmaceutical companies can mutually use IPD in the pre-competitive phase. We will also discuss legal restrictions on personal information protection and the appropriate balance between data utility and privacy in sharing IPD.
Speaker(s)
Approach to Clinical Trial Data Sharing Using Consortium Platform
Wataru Ohtsuka, MSc
Chugai Pharmaceutical Co., Ltd., Japan
Digital Strategy Dept.
An Experience of Data Sharing Utilization
Akihiro Hirakawa, PhD
Tokyo Medical and Dental University, Japan
Professor,Clinical Biostatistics,Graduate School of Medical and Dental Sciences
European Union, Japan And U.S. Privacy Law: Implications for Data Sharing
Nick Wallace, JD
Ropes & Gray LLP, United States
Data De-Identification Technology to Ensure a Proper Balance Between Data Utility and Privacy Protection
Kazuhiro Minami, PhD
Institute of Statistical Mathematics, Japan
Associate professor, Department of Statistical Modeling,