Drug Evaluation Committee Data Linkage Initiative - Proposals from the Frontline of Medical Care and Clinical Trials
August 2023
Although the use of eSource for electronic medical record data in clinical trials (hereinafter referred to as “data integration”) has long been a topic of discussion, there are still many challenges to establishing it as a standard data collection method.
Against this backdrop, in November 2020, Dr. Toshihiko Doi (National Cancer Center) proposed, “Rather than individual medical institutions or clinical trial sponsors, let’s bring together multiple medical institutions, clinical trial sponsors,IT vendors—rather than individual medical institutions or sponsors—to begin discussions on promoting data integration starting with what is feasible.”
With the support of two medical institutions, three IT vendors, five pharmaceutical companies, and volunteers from the Japan Pharmaceutical Manufacturers Association who endorsed this initiative, discussions initially focused on clinical laboratory data. Based on the current status of data recorded in electronic medical records, technical issues were identified and challenges for constructing a data integration model were summarized.
We are publishing this document on this website in the hope that, by building on this work—which is closely related to the deliverables* released in June 2023—and further stimulating discussion among numerous stakeholders, we can accelerate the implementation of data integration.
Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association (
) Data Science Subcommittee
Data Linkage Initiative - Proposals from the Frontline of Medical Care and Clinical Trials