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16th DIA Japan Annual Meeting 2019

Delivering Rational Medicine for All People in the Globe


[S17] Sharing Individual Participant Data (IPD) from Clinical Trials and Personal Information Protection

Session Chair(s)

Tomoko  Kato

Tomoko Kato

  • Head Programming, Biostatistics & Programming Clinical Services & Operations
  • 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)

Wataru  Ohtsuka, MSc

Approach to Clinical Trial Data Sharing Using Consortium Platform

Wataru Ohtsuka, MSc

  • Digital Strategy Dept.
  • Chugai Pharmaceutical Co., Ltd., Japan
Akihiro  Hirakawa, PhD

An Experience of Data Sharing Utilization

Akihiro Hirakawa, PhD

  • Project Associate Professor, Department of Biostatistics and Bioinformatics
  • Graduate School of Medicine, The University of Tokyo, Japan
Nick  Wallace, JD

European Union, Japan And U.S. Privacy Law: Implications for Data Sharing

Nick Wallace, JD

  • Ropes & Gray LLP, United States
Kazuhiro  Minami, PhD

Data De-Identification Technology to Ensure a Proper Balance Between Data Utility and Privacy Protection

Kazuhiro Minami, PhD

  • Associate professor, Department of Statistical Modeling,
  • Institute of Statistical Mathematics, Japan