Drug Evaluation Committee Study on introduction and utilization of clinical trial methods that do not depend on visits to medical institutions
Clinical Evaluation Subcommittee
September 2020
In recent years, a new clinical trial method (Decentralized Clinical Trial, DCT) has been introduced, in which patients can participate in clinical trials without having to visit a medical institution, by utilizing IoT devices such as wearable devices and online medical care, etc., to decentralize the clinical trial process that is concentrated at the implementing medical institution. DCTs (Decentralized Clinical Trials) are attracting attention.
Task Force 3 of the Clinical Evaluation Subcommittee 2019 has prepared a document for not only pharmaceutical companies but also medical professionals, patient/patient organizations, regulatory authorities, and the healthcare industry, with the aim of investigating the current status and methods in Japan and abroad and organizing issues for the implementation of DCTs in Japan.
DCTs provide patients with opportunities to participate We hope that DCTs will be widely used as a clinical trial method to expand opportunities for patient participation and, as a result, improve the efficiency of clinical trials as a whole and lead to the creation of innovative drugs. We hope that this document will be of some help in introducing DCT.
- TF-3 Report (2.6MB)
- Attachment 1: Summary of individual DCT studies conducted overseas (626KB)
- Attachment 2: Results of Questionnaire Survey of Companies Participating in this TF (1) (697KB)
- Attachment 3: Results of Interviews with Telemedicine Experts and Clinical Trial Service Providers (362KB)
- Attachment 4: Results of Questionnaire Survey of TF Participating Companies (2) (331KB)
- Attachment 5: Results of Interviews with Pharmaceutical Industry Policy Research Institutes, Service Providers for Clinical Trials, etc. (1MB)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables