Drug Evaluation Committee Survey and compilation of regulations and actual status of utilization concerning clinical trials that do not depend on visits to medical institutions

Clinical Evaluation Subcommittee

In recent years, the use of clinical trials that do not rely on visits to Investigator Site (Decentralized Clinical Trial, "DCT") has been increasing globally due to the spread of digital technology and the concept of Patient Centricity in drug development. In Japan, DCTs are expected to be further utilized from the perspectives of improving patient access to clinical trials and promoting clinical trials, and companies and medical institutions are now considering the introduction and utilization of DCTs.

The Clinical Evaluation Subcommittee Special Project 1 (FY2024-2025) aims to further utilize DCT based on the issues and needs identified from the results of the most recent JPMA member company survey and hearings, and to survey and organize the regulations and case studies in each country, as well as the actual utilization status of partner medical institutions, which have yet to introduce DCT to a limited extent. The document is intended not only for pharmaceutical companies, but also for healthcare professionals, patients/patient groups, regulatory authorities, and the healthcare industry. We hope that this document will contribute to the realization of an effective and efficient clinical trial environment utilizing DCTs by deepening understanding and utilization of DCTs and leading to discussions toward their optimization.

Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee Clinical Evaluation Subcommittee
Special Projects for FY 2024 and 2025 1

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