Drug Evaluation Committee Regulations related to CTDS (Clinical Trial Data Sharing) and points to keep in mind when responding to them
April 2020
Regarding the sharing of Individual Patient Data (IPD) from clinical trials (CTDS), the Data Science Subcommittee has previously released reports introducing the overview of CTDS and de-identification techniques, as well as newsletters summarizing the latest developments.Although CTDS has developed primarily in Europe and the United States, an increasing number of companies in Japan are now adopting CTDS, and the utilization of data is advancing. At the same time, however, the rules that must be followed when implementing CTDS—such as those regarding data privacy protection—are becoming more numerous and complex, making compliance with regulations increasingly difficult.
One method for complying with CTDS-related regulations is the anonymization of IPD; however, it is not easy to process data to a level that meets the definitions of “anonymized processed information” under Japan’s Personal Information Protection Act or “anonymous information” under the EU General Data Protection Regulation (GDPR) while maintaining the data’s usefulness.Another approach is obtaining consent, but under the GDPR, there are various hurdles to obtaining consent for the secondary use of data.
In light of this situation, this report focuses primarily on the GDPR and also introduces various regulations in Japan, including future trends. We hope this report will be of assistance to those involved in CTDS and clinical trial operations as they organize and review CTDS-related regulations and compliance measures.
Notes
Please note that this report does not represent any official policy of the JPMA regarding regulatory compliance.
Regulations Related to CTDS (Clinical Trial Data Sharing) and Points to Note for Compliance (746KB)