Drug Evaluation Committee Regulations related to CTDS (Clinical Trial Data Sharing) and points to keep in mind
Data Science Subcommittee
April 2020
The Data Science Subcommittee has released a number of reports on clinical trial data sharing (CTDS), including an overview of CTDS and de-identification technologies, as well as a newsletter summarizing the latest status of CTDS. CTDS has developed in Europe and the U.S. first, but the number of companies working on CTDS is increasing in Japan as well, and the utilization of data is progressing. On the other hand, the number of rules to be complied with in implementing CTDS, such as data privacy protection, is increasing and becoming more complex, making it more difficult to comply with regulations.
One way to comply with regulations related to CTDS is to anonymize IPD, which is a method of maintaining the usefulness of data while also complying with the "anonymized information" requirements of the Japanese Personal Information Protection Law and the EU General Data Protection Law. However, it is not easy to process the data to a level that meets the definition of "anonymized information" under Japan's Personal Data Protection Law and the EU General Data Protection Regulation (GDPR), while maintaining the usefulness of the data. Another method is to obtain consent, but under the GDPR, there are various hurdles in obtaining consent for secondary use of data itself.
In light of this situation, this report organized mainly on GDPR, and also introduced various regulations in Japan, including future trends. We hope that this report will help those involved in CTDS and clinical trial operations when organizing and reviewing CTDS-related regulations and responses.
Notes
Please note that this report does not indicate any kind of policy as the Pharmaceutical Manufacturers Association of Japan (PMAJ) regarding regulatory responses.
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