Drug Evaluation Committee Data Linkage Initiative: Recommendations from the Frontlines of Medical Care and Clinical Trials
Although eSource utilization of electronic medical record data in clinical trials (hereinafter referred to as "data linkage") has been discussed continuously for a long time, there are still many challenges to establish it as a common data collection method.
Against this background, in November 2020, Dr. Toshihiko Doi (National Cancer Center) initiated the idea of "starting discussions to promote data linkage from where we can, by getting together with multiple medical institutions, trial sponsors, and IT vendors, rather than individual medical institutions and trial sponsors," and the consortium The "Data Linkage Concept Study Group" was planned based on the idea of "starting discussions to promote data linkage from where we can.
The discussion focused first on clinical laboratory data, and then on the current status of data recorded in electronic medical records.
The results of the discussion were published in June 2023. We are releasing it on this website in the hope that it will accelerate the implementation of data linkage by further stimulating discussions among many stakeholders based on this deliverable, which is closely related to the deliverable* that was released in June 2023.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Data Science Subcommittee
Data Linkage Concept - Proposals from the field of medical care and clinical trials