Drug Evaluation Committee Questionnaire on the status of introduction of DCT and results of each DCT method
October 2024
Regarding “Decentralized Clinical Trials(DCT, Decentralized Clinical Trial)—a clinical trial methodology that does not rely on visits to medical institutions—the Data Science Subcommittee released a report titled “Data Flow in DCTs and Ensuring Data Reliability” in August 2022. This report summarizes the results of a survey conducted in fiscal year 2021 regarding the status of DCT adoption and challenges associated with various methodologies.
The Data Science Subcommittee’s FY2023 Task Force 1-2 conducted a similar survey to assess changes in DCT adoption since FY2021 and has compiled the results.This report includes changes since fiscal year 2021, new challenges that have emerged as adoption has progressed for certain methods, and recommendations and points to note regarding ensuring reliability. We hope this report will not only serve as a source of information for DCT use but also help further the adoption and promotion of DCT.
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee
Data Science Subcommittee, FY2023 Task Force 1-2