[Decentralized Clinical Trials in Cancer Patients]

Clinical trials are conducted at a limited number of medical institutions, and patients living in areas far from these sites sometimes give up participating in clinical trials due to the time, financial, and physical burdens associated with hospital visits, even if they wish to do so. A survey conducted by the National Cancer Center Hospital has revealed that participation rates in clinical trials tend to decrease when travel time exceeds 120 minutes one way. Additionally, among patients who underwent cancer panel testing under the national health insurance, only 9.4% received the treatments recommended by the expert panel, partly due to the inability of patients living far away to travel to urban medical institutions. The decentralized clinical trials(DCTs)discussed in this paper are one potential solution to these issues. This article will cover the latest regulatory requirements for DCTs, the different types of DCTs, and the necessary preparations for medical institutions and partner sites, based on a case from the National Cancer Center Hospital. It will also address topics such as eConsent, telemedicine, sharing of trial data, the delivery of investigational medicinal products, and medical expenses associated with DCTs.