Drug Evaluation Committee DM Transformation Topic "Data Flow and Ensuring Reliability in DCT
August 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 FY2021 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 regarding “eSource and DCT.”
As part of the JPMA’s output on DCT, the Clinical Evaluation Subcommittee of the Drug Evaluation Committee has already released “Study on the Introduction and Utilization of Clinical Trial Methods Not Dependent on Visits to Medical Institutions (September 2020)”and “Study on the Utilization of Clinical Trial Methods Not Dependent on Visits to Medical Institutions: A Guide to Implementation in Japan (August 2021)” have already been released. Building on these, this report summarizes the points to consider when introducing and operating DCTs from a data management perspective, with “ensuring data reliability” as a key focus.
We hope this document will serve as a resource to help companies—whether they have not yet considered DCT, are currently evaluating it, are preparing for implementation, or have already implemented it—overcome their current challenges and move forward.
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee,
, DS Subcommittee, FY2021 Task Force 1