Drug Evaluation Committee Examination of Methodology for Data De-identification for CTDS (Clinical Trial Data Sharing)
Data Science Expert Committee
February 2021
The Data Science Subcommittee has released several reports on clinical trial data sharing (CTDS), including a report introducing an overview of CTDS and de-identification techniques, a newsletter summarizing the latest status, and a report on related regulations and points to keep in mind when dealing with CTDS.
CTDS started in Europe and the U.S. first, but the number of companies working on CTDS is increasing in Japan as well, and the use of data is progressing. On the other hand, it is difficult to imagine exactly how the process of de-identification (de-identification) is carried out to reduce the risk of identification of the person associated with the data, and to what extent it affects the usefulness of the data. This can be an obstacle for companies to define the de-identification process, and also for researchers who use de-identified data to understand what restrictions are placed on the data.
In light of this situation, this report introduces not only the de-identification process but also the results of the de-identification process using actual data, with the aim of providing a concrete image of how the de-identification process is carried out and to what extent it affects the usefulness of the data. We hope that this report will help those involved in CTDS and clinical trial operations as they promote CTDS activities. We hope that this report will be of some help to those involved in CTDS and clinical trial operations as they promote CTDS activities.
Study of Data De-identification Methods for CTDS (Clinical Trial Data Sharing) (663KB)