Drug Evaluation Committee Current Status and Issues of DDC/EHR Data Linkage
September 2022
In light of major changes in the clinical trial landscape, data flows have become more diverse and complex, making it an urgent priority to ensure data quality and reliability.Since addressing these challenges is directly linked to the future of data management, the 2021 Task Force 1 of the Data Science Subcommittee of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) examined three topics—“DDC/EHR Data Integration,”, “eSource and DCT,” and “Efficient Data Management Operations Based on Fitness for Purpose.”
This report summarizes the findings of the discussion on “DDC/EHR Data Integration.”
As a deliverable regarding the utilization of DDC (Direct Data Capture) and EHR (Electronic Health Record) data in clinical trials, the JPMA Data Science Subcommittee released “Overview of eSource (DDC and EHR) and Considerations for Implementation” in March 2020.
Building on this, this report assesses the degree of adoption and trends in the use of DDC and EHR data in clinical trials within the pharmaceutical industry—including CROs and medical institutions—since fiscal year 2019, and proposes challenges and countermeasures to further promote their widespread adoption.
We hope this report will help drive the streamlining and acceleration of clinical trials in the pharmaceutical industry.
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee,
DS Subcommittee, FY2021 Task Force 1