Drug Evaluation Committee Results of Questionnaire on the Status of Introduction of DCT and on Each DCT Method
Data Science Expert Committee
October 2024
The Data Science Subcommittee released "Data Flow in DCT and Ensuring Reliability" in August 2022 regarding "Decentralized Clinical Trial (DCT)," which is a clinical trial method that does not depend on visits to medical institutions. The Data Science Subcommittee also summarized the results of a questionnaire survey conducted in FY2021 on the status of introduction of DCT and issues related to each method.
In Task Force 1-2 of the Data Science Subcommittee FY2023, a similar questionnaire survey was conducted again with the aim of confirming changes in the status of DCT implementation since FY2021. This deliverable includes the changes since FY2021, new issues that have emerged as implementation has progressed for some methods, and recommendations and points to keep in mind regarding ensuring reliability. We hope that this report will not only disseminate information on the use of DCTs, but also help to further introduce and promote DCTs.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Data Science Subcommittee Task Force 1-2 for FY2023