ZHOU Wenjing, WU Minjiang, LIU Shaoxuan, LOU Xiaohuan, CAILIN Bowen, YU Man, MO Enpan, ZHANG Xun
Objective To analyze the status of decentralized clinical trial (DCT) technology in non-rare diseases,and to discuss the concerns and countermeasures in the implementation process. Methods By convenient sampling,drug clinical trial projects carried out by four large public Grade III hospitals in Guangdong Province from 2021 to 2024 were selected as research objects and descriptive statistical analysis was carried out using SPSS 29.0 software.The technical application of DCT elements was analyzed in six aspects:electronic informed consent,direct to patient,remote visits,direct delivery of samples,remote monitoring of safety data,and digital medical technology. Results A total of 422 drug clinical trials were included,of which 165 (39.1%) involved remote visit technology,14.5% remote monitoring of safety data,10.4% direct mail of samples,6.4% digital medical technology,3.6% direct access to clinical trial drugs,and 0.9% involved electronic informed consent.In addition,the proportion of DCT elements used in international multi-center clinical trials was higher than that in domestic multi-center clinical trials in five aspects:remote visits,safety data monitoring,direct delivery of samples,digital medical technology,and direct access to experimental drugs.Regarding remote visits,direct to patient,direct delivery of samples,and digital medical technology,the proportion of cardiovascular system diseases and circulatory system diseases using the above DCT elements is relatively high,65.2%,17.4%,17.4%,4.3%,respectively. Conclusions There are great differences in applying different DCT elements in clinical trials of non-rare diseases.At present,remote visits and remote safety data monitoring are widely used.Overall,the application rate of DCT elements is relatively low and needs continuous promotion and popularization.Based on the concept of "patient-centered",the promotion and application of DCT in clinical trials in China should be promoted with the goal of quality assurance and efficiency improvement of clinical trials.