The Mt.Fuji Foundation for Healthcare Innovation and Cluster Development (main office: Nagaizumi-cho, Sunto-gun, Shizuoka Prefecture; President: Mayumi Otsubo; hereinafter “Pharma Valley Center”), which operates the Shizuoka Clinical Trial Network, and DCT Japan Inc, (headquartered in Chuo-ku, Tokyo; President: Shinsuke Muto, hereinafter “DCT Japan”) have entered into a business alliance agreement concerning satellite medical institution business in the implementation of decentralized clinical trials (DCT).
Through this alliance, a system will be established to provide more patients in Shizuoka Prefecture with the opportunity to participate in decentralized clinical trials supported by DCT Japan through Pharma Valley Center.
Background and Objectives of the Collaboration
Decentralized clinical trials (DCT) that eliminate the need for patients to visit clinical trial sites by utilizing IoT technologies such as wearable devices, online medical treatment and home visit nursing have been actively adopted mainly in Europe and the United States to reduce the burden of patient visits based on the concept of Patient Centricity. In Japan, the use of DCT has been rapidly increasing since the spread of the novel coronavirus infection.
Furthermore, as the problems of drug lag and drug loss remain serious, there is a need to establish a system for implementing clinical trials which satisfy international standards, as part of efforts to resolve these issues. DCTs are also attracting attention from the perspective of clinical trial implementation systems, as they are expected to speed up the process of subject enrollment and enable patient recruitment from a wide area, which has been difficult in conventional clinical trials.
Roles of Both Parties
Under this partnership, DCT Japan will share information on the decentralized clinical trials it supports with Pharma Valley Center, and Pharma Valley Center will use this information to recruit satellite sites that can cooperate in conducting clinical trials from medical institutions that are members of the Shizuoka Clinical Trials Network. This will create opportunities for more patients in Shizuoka Prefecture to participate in clinical trials.
In concluding this agreement, Kenji Hashimoto of the Pharma Valley Center's Drug Discovery and Clinical Research Support Department commented, “We believe that collaboration between medical institutions conducting clinical trials and satellite medical institutions is essential to accelerate the introduction and spread of decentralized clinical trials in Japan. We also believe that decentralized clinical trials will be an important key to accelerate future medical innovation. Through this business alliance, we will strive to provide a better clinical trial environment by deepening collaboration among sites within and outside the Shizuoka Clinical Trials Network and creating opportunities for more patients in Shizuoka Prefecture to participate in clinical trials. We will also work to increase the case pooling capacity by conducting decentralized clinical trials, reduce development costs for sponsors, and eliminate the drug lag in Japan.”
Hiroyuki Kakigi, Director of DCT Japan, said, “We have been supporting DCT with solutions such as online medical care and home nursing, and have been working to expand our network of satellite medical institutions in order to respond to diversifying needs and further develop and promote DCT in Japan. We believe that the opportunity to promote the satellite medical institution business with Pharma Valley Center, which is actively engaged in the development of advanced medical care including clinical trials, will be a great foundation not only for our company, but also for the spread of DCT in Japan.”
Future Outlook
Starting with this partnership, DCT Japan aims to proactively build a cooperative framework with regional medical cooperation networks and clinical trial networks that exist throughout Japan to bring clinical trial opportunities to patients nationwide. Through the spread of DCT, we will greatly improve the convenience and ease of participation for patients in clinical trials, and provide new possibilities for pharmaceutical companies and healthcare professionals. This is the mission and driving force behind DCT Japan.
About DCT:
DCT (Decentralized Clinical Trial) is a clinical trial that does not rely on visits to medical institutions by utilizing IoT such as wearable devices, online medical care and home nursing care by nurses. This reduces the burden of patient visits due to their health status and physical distance from the clinical trial site and contributes to improved subject enrollment and lower trial costs.
About Pharma Valley Center:
The Pharma Valley Center is the core support organization for the Pharma Valley Project, which aims to promote advanced research and development of world-class advanced medical care and technology, and the promotion and concentration of advanced health industries ranging from medicine to wellness industries, backed by a favorable transportation infrastructure, natural environment, and a concentration of health-related industries. In collaboration with Shizuoka Prefecture and the Shizuoka Cancer Center, we promote the entry of companies into the medical and health industry and support their commercialization of products and commercialization through local industry-academia-government-finance networks. We also operate the Shizuoka Clinical Trials Network and work with medical institutions registered with the network to revitalize clinical trials in Shizuoka Prefecture.
http://www.fuji-pvc.jp/
For inquiries regarding this matter, please contact
DCT Japan Inc.
Public Relations:
pr@dctj.co.jp